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Flu Vaccination and Older Hospitalized Adults with Cardiovascular Disease: What are the Benefits?

A study published in the International Journal of Infectious Diseases found flu vaccines reduced in-hospital deaths and recurrent hospitalizations for older hospitalized adults with cardiovascular disease.

FDA Approves Ustekinumab for Treating Psoriatic Arthritis in Children

Janssen Pharmaceutical Companies of Johnson & Johnson announced the approval of ustekinumab as a new treatment option for patients aged 6 years or older with active psoriatic arthritis.

Care Fragmentation Thwarts Progress in Diabetes Reduction

More financial incentives for high-value services, greater data interoperability are needed to address problem

Examining Connections Between Migraine and Mental Health

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Articles

Your weekly roundup of the latest news from Drug Topics®.

News Roundup: August 1 to August 5

The national rate of people without health insurance dropped to a record low 8% in the first quarter of 2022, according to federal researchers.

 estimated about 26.4 million people lacked health insurance in the first quarter of 2022, down from an annual estimated of 31.6 million people without insurance in 2020. That indicates about 5.2 million people – an estimated 4.1 million adults aged 18 to 64 years, and 1 million children aged 17 years or younger – gained health coverage since 2020.

The figures were in an analysis published Aug. 2 by the Office of Health Policy in the 

Assistant Secretary for Planning and Evaluation

 (ASPE) in the U.S. Department of Health and Human Services (

). APSE credited the administration of President Joe Biden for 2021 actions that built on large reductions in uninsured rates due to the 2014 Affordable Care Act (ACA).

“Overall, these results highlight the significant gains in health insurance coverage that occurred in 2021 and early 2022 associated with the Biden-Harris Administration’s policies to support health insurance expansion,” the report said. “These gains build on the large reductions in the uninsured rate that occurred after the implementation of the Affordable Care Act (ACA) in 2014, which research demonstrates produced improved health outcomes, better access to care, and improved financial security for families.”

Before 2022, the previous record low uninsured rate was 9% in 2016, for the annual rate. The lowest quarterly estimate was 8.6% in the first quarter of 2016, though the report noted quarterly estimates are more volatile due to smaller sample sizes.

About 5.4% of adults aged 18 to 64 years reported having ACA Marketplace coverage in early 2022, up about 2 million people from the 4.4% Marketplace coverage rate of 2020.

The American Rescue Plan,the administration’s response to the economic woes caused by the COVID-19 pandemic, included enhanced subsidies for people seeking insurance through the Marketplace at HealthCare.gov. The subsidies were retroactive to the start of 2021, boosted the size of premium tax credits for people with incomes between 100% and 400% of the federal poverty level (FPL), and extended tax credits to those with incomes above 400% of the FPL for the first time, the report said.

The Inflation Reduction Act, introduced in the Senate, would extend ACA Marketplace insurance subsidies through 2025.

“And I'm hopeful that with Congressional action we can continue the work to lower costs for more Americans by both extending the enhanced Affordable Care Act tax credits that have helped drive the uninsured rate to an all-time low and increasing the affordability of prescription drugs for Medicare beneficiaries – reducing their cost sharing and allowing Medicare to negotiate a better deal on prescription drug prices,” HHS Secretary Xavier Becerra said in a statement.

Without an extension, there have been predictions that millions of people will face premium increases for Marketplace plans, leading to a decline in overall health care spending. Regardless of subsidies, at least one report has forecasted a spike in 2023 premiums due to inflation.

Additional factors for the declining uninsured rate included the continuous enrollment provision in Medicaid for adults aged 19 to 64 with incomes less than 138% of the FPL.

Five states expanded Medicaid for adults in 2019 and 2020. From 2018 to 2020, the most recent year data are available, those states had the largest decreases in uninsured rates: Idaho (-8.4%), Virginia (-7.2%), Maine (-4.9%), Nebraska (-2.8%), and Utah (-1.4%).

Two states that expanded Medicaid in 2021 posted increases in the rates of uninsured: Missouri (1.7%) and Oklahoma (2.9%). The report did not explain why.

Among the 50 states and the District of Columbia, only four – Washington D.C., Massachusetts, Rhode Island and Vermont – had single digit uninsured rates for those who qualify for Medicaid.

 that “Medicaid expansion was shown to have improved preventive care and financial security for adults with disabilities.”

This article originally appeared on Medical Economics.

More people getting health coverage, but 26.4 million still don’t have it.

Rate of People Without Health Insurance Hits Record Low

Optum, a UnitedHealth Group company, is working with Sanofi to offer a 30-day supply of commonly used Sanofi insulins for $35 to people with diabetes who do not have insurance.

The insulins will be available via its online health services and products retailer 

“The need for affordable insulin is urgent, especially for uninsured populations,” said Heather Cianfrocco, chief executive officer of Optum Rx in a news release.

 “By working with Sanofi, we will improve access and lower costs for people who need this life-saving medication.”

 plans to eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and several drugs used to treat emergencies.

Additionally, California Governor Gavin Newsom 

 to contract to make insulin at a cheaper price and sell it at close to at-cost and available to all.

Of that amount, $50 million will go to low-cost insulin products and $50 million will go toward a California-based insulin manufacturing facility to provide new, high-paying jobs and a stronger supply chain for the drug, the governor said via video.

“Nothing, nothing epitomizes market failures more than the cost of insulin,” with people spending $300 to $500 out of pocket per month for it, Newsom said. “California is now taking matters into our own hands.”

Here’s how the Optum program works: individuals can access 

 to determine whether their insulin is part of the affordability program, get qualified and download an insulin savings card, and then fill their prescription at the $35 price point at any retail pharmacy.

A mail-service option will soon be available for people who prefer home delivery through the Optum Store.

Optum to offer lower-cost Insulin for uninsured people living with diabetes on Optum Store. News release. Optum. August 1, 2022. Accessed August 2, 2022. 

https://www.optum.com/about-us/news/optum-offer-lower-cost-insulin.html

UnitedHealthcare to eliminate out-of-pocket costs on several prescription drugs, including insulin, for eligible members. July 15, 2022. Accessed August 3, 2022. 

https://www.unitedhealthgroup.com/newsroom/2022/2022-07-15-uhg-eliminate-out-of-pocket-costs.html

The company will provide uninsured patients nationwide an avenue for getting the drug at a far more affordable price point.

Optum Joins Others Offering Affordable Insulin

Now more than ever, it’s essential for patients— particularly those who are at risk—to be vaccinated against influenza. Adults 65 and older, individuals with comorbidities, people of color, and individuals of lower socioeconomic status are at higher risk of illness. Getting vaccinated helps protect these vulnerable populations.

What strains have been chosen for this season’s vaccines?

On February 25, 2022, the World Health Organization (WHO) announced the strains selected for the 2022-2023 flu season vaccines after reviewing the data of circulating virus (see sidebar).

On March 3, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to approve the strains selected by WHO.

What are the new recommendations for the current flu season?

At a meeting in June 2022, the Advisory Committee on Immunization Practices recommended that adults 65 and older receive high-dose influenza vaccines for better protection.

 These vaccines include quadrivalent adjuvanted inactivated influenza vaccine (aIIV4), quadrivalent high-dose inactivated influenza vaccine (HD-IIV4), or quadrivalent recombinant influenza vaccine (RIV4).

In May 2021, the FDA approved the cell-based vaccine Flucelvax (Seqirus).

 This extends the age of coverage of the vaccine to children 6 months and older. A phase 3 clinical study supported this approval, showing that the vaccine’s safety and immunogenicity was equivalent to that of other standard quadrivalent vaccines for children of ages 6 months to 5 years.

 “These data, presented at the Pediatric Academic Societies 2021 Virtual Meeting on May 1, 2021, represent the first US phase 3 study of a cell- based influenza vaccine in this population,” the press release noted.

Moderna is conducting ongoing clinical trials for its mRNA-1230 combination vaccine, which is designed to protect against influenza, COVID-19, and respiratory syncytial virus using the company’s mRNA platform. In a press release distributed ahead of the company’s annual Vaccines Day— held this year in March 2022—Stephen Hoge, MD, president of Moderna said, “We are pleased to add a combination respiratory vaccine candidate against 3 of the leading causes of respiratory disease in older adults, and a vaccine against all 4 of the endemic human coronaviruses as part of our strategy to address the substantial global burden of respiratory infections....Our goal is to develop vaccines to address respiratory infections and eventually combine many into a single annual booster vaccine, with the aim of reducing the significant morbidity and mortality caused by these viruses.”

On July 1, 2022, the FDA approved the license for Sanofi’s Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent influenza vaccines for the 2022-2023 season. Fluzone and Flublok are the only influenza vaccines proven by randomized controlled trials to prevent more cases in older adults, according to Sanofi’s press release.

 Sanofi said Fluzone has 10 years of evidence in protecting adults 65 and older from flu-related hospitalizations.

“In a clinical study, Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18 [and older] that was proven to be 30% more effective than a standard-dose vaccine at preventing flu infection in over 9000 adults 50 [and older]. In adults 50 [and older], the most common [adverse] effects were tenderness and/or pain at the injection site, headache, and tiredness,” the press release stated.

Finally, Novavax, Inc, is developing a COVID-19–influenza combination vaccine. In April 2022, Novavax reported the vaccine was well tolerated and immunogenic, and that the phase 2 confirmation trial will begin toward the end of 2022.7 In the news release, Gregory M. Glenn, MD, president of research and development at Novavax, said the company is continuing “to evaluate the dynamic public health landscape and believes there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza. We’re encouraged by these data and the potential path forward for a combination COVID-19 influenza vaccine [and] stand-alone vaccines for influenza and COVID-19.”

1. Recommendations announced for influenza vaccine composition for the 2022-2023 northern hemisphere influenza season. News release. World Health Organization; February 25, 2022. Accessed July 5, 2022. 

https://www.who.int/news/item/25-02-2022-recommendations-announced-for-influenza-vaccine-composition-for-the-2022-2023-northern-hemisphere-influenza-season

2. Vaccines and Related Biological Products Advisory Committee March 3, 2022 meeting announcement. FDA. Updated March 25, 2022. Accessed July 5, 2022. 

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-3-2022-meeting-announcement

3. ACIP flu meeting update: Flu vaccines worked better than reported & ACIP recommends specific vaccines for seniors. CDC. Published June 23, 2022. Accessed July 19, 2022. 

https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm

4. Seqirus receives FDA approval of its cell-based quadrivalent influenza vaccine, expanding the age indication to include children as young as six months. News release. Seqirus; October 15, 2021. Accessed July 5, 2022. 

https://www.prnewswire.com/news-releases/seqirus-receives-fda-approval-of-its-cell-based-quadrivalent-influenza-vaccine-expanding-the-age-indication-to-include-children-as-young-as-six-months-301401332.html

5. Moderna announces new development programs ahead of 3rd annual Vaccines Day. News Release. Moderna; March 22, 2022. Accessed July 5, 2022. 

https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-New-Development-Programs-Ahead-of-3rd-Annual-Vaccines-Day/default.aspx

6. Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+. News release. Sanofi; July 1, 2022. Accessed July 5, 2022. 

https://www.prnewswire.com/news-releases/sanofi-flu-vaccines-licensed-and-approved-for-2022-2023-influenza-season-including-cdc-preferred-higher-dose-vaccines-for-adults-65-301579875.html

7. Initial results from Novavax’ COVID-19-influenza vaccine trial are first to show feasibility of combination vaccine. News Release. Novavax Inc; April 20, 2022. Accessed July 5, 2022. 

https://www.prnewswire.com/in/news-releases/initial-results-from-novavax-covid-19-influenza-vaccine-trial-are-first-to-show-feasibility-of-combination-vaccine-839902859.html

Learn about the selected strains for this year’s flu season, flu vaccine recommendation changes, and newly licensed and forthcoming vaccine options

What's Coming in the 2022-2023 Flu Season 

The FDA approved the first fully interchangeable biosimilar to the blockbuster eye disease medication Lucentis (ranibizumab).

Cimerli (ranibizumab-eqrn), Coherus BiosSciences, is interchangeable with Lucentis (ranibizumab injection) for all 5 indications, “meeting the FDA’s rigorous standards to the reference product, including safety, efficacy, and quality,” Coherus said in a news release.

Lucentis, indicated for wet age-related macular degeneration (AMD), visual impairment due to choroidal neovascularisation (CNV), visual impairment due to diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV), boasted revenue of 

Coherus expects Cimerli to be available in both dosages, 0.3 mg and 0.5 mg, in October. When asked for comments on the cost of Cimerli, Kelly Perkins, consultant for Red House Communications, told 

® "We are not commenting on pricing at this time."

The new biosimilar will provide “both greater treatment access and choice for patients, payors and providers in the US retinal disease community,” said Paul Reider, chief commercial officer of Coherus BioSciences.

“Retinal disease is a significant public health issue with certain conditions leading to vision loss or impairment. As a practitioner committed to the safety and well-being of patients, having an approved biosimilar product that is interchangeable with Lucentis—with a similar safety and efficacy profile—is great news for patients," added Dr. Peter K. Kaiser, professor of ophthalmology at the Cole Eye Institute/Cleveland Clinic in Ohio, and an advisor to Coherus.

"Ocular anti-VEGF agents have enabled many people with retinal disease to retain and even gain vision. I am pleased to have an additional treatment option for my patients,” Kaiser added.

The approval of Cimerli and its interchangeability indication was based on

 In the head-to-head study, Cimlerli met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.

Secondary endpoints included change from baseline in BCVA at 48 weeks, change from baseline in FCB retinal thickness at 48 weeks, safety and immunogenicity. The overall safety and immunogenicity profile was comparable with Lucentis.

“Based on the totality of evidence, Cimerli demonstrates that clinical outcomes are expected to be the same for any given patient across all indications,” Coherus said. "As an interchangeable biosimilar, Cimerli is not expected to result in safety risk or reduction in efficacy in any way, when substituted for Lucentis.”

Although Cimerli is the first interchangeable biosimilar to Lucentis, the biosimilar Byooviz (Biogen and Samsung Bioepis) has been on the market since July. It launched at a 40% discount — 

FDA approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the first and only interchangeable biosimilar to Lucentis® for all five indications, with 12 months of interchangeability exclusivity. News release. Coherus Biosciences. August 2, 2022. Accessed August 3, 2022. 

https://www.globenewswire.com/news-release/2022/08/02/2490955/0/en/FDA-Approves-Coherus-CIMERLI-ranibizumab-eqrn-as-the-First-and-Only-Interchangeable-Biosimilar-to-Lucentis-for-All-Five-Indications-with-12-Months-of-Interchangeability-Exclusivity.html

Holz F, Oleksy P, Ricci F, et al. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. 

. 2022 Jan;129(1):54-63. doi: 10.1016/j.ophtha.2021.04.031.

Cimerli can be used for all 5 indications. No information on pricing has been released.

First Interchangeable Biosimilar to Lucentis Launches

ThoughtSpot 2022 may be over, but this video highlights the events and opportunities from the event.

Videos

A quick video recap of all the sessions and events ThoughtSpot 2022 had to offer.

Highlights from ThoughtSpot 2022

On April 26, 2022, the FDA approved inhibitor that targets CYP51 and is available as oteseconazole (Vivjoa), an oral azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in women with a history of RVVC who are not of reproductive potential.

 Oteseconazole is an azole metalloenzyme a single-drug regimen or in combination with fluconazole. Antifungal therapy may be instituted before the results of the cultures are known and adjusted accordingly when results become available.

The first 2 clinical trials (NCT03562156 and NCT03561701)

 included a total of 656 adults and postmenarcheal pediatric women with RVVC who were randomly assigned to receive either oteseconazole only or placebo.

 evaluated safety of oteseconazole vs fluconazole and placebo in 219 adults and postmenarcheal pediatric women with RVVC.

Trials 1 and 2 each included an open-label induction phase and an 11-week maintenance phase. During the induction phase, participants received 3 sequential doses of fluconazole 150 mg every 72 hours on days 1, 4, and 7. At 14 days following the first fluconazole dose, if the acute VVC episode was resolved, participants were randomly assigned 2:1 to receive either oteseconazole 150 mg or placebo for 7 days, followed by 11 weekly doses during the maintenance phase; 326 and 330 patients, respectively, entered this phase. Primary efficacy end points were the proportion of patients with greater than or equal to 1 culture-verified acute VVC episode during the maintenance phase through week 48.

 The average percentage of patients with an acute VVC episode was lower in the oteseconazole group vs the placebo group in both trials (6.7% vs 42.8% and 3.9% vs 39.4%, respectively).

Trial 3 evaluated the efficacy and safety of oteseconazole vs fluconazole and placebo. This trial also included induction and maintenance phases. Participants received a total dose of oteseconazole 150 mg over 2 days (600 mg [4 × 150 mg] on day 1 and 450 mg [3 × 150 mg] on day 2) or 3 sequential doses of fluconazole 150 mg every 72 hours on days 1, 4, and 7. Patients returned 14 days after the first dose and moved to the maintenance phase if the acute VVC episode was resolved. During the maintenance phase, patients received oteseconazole 150 mg or placebo weekly for 11 weeks.

 The primary efficacy end point was the proportion of patients with greater than or equal to 1 culture-verified acute VVC during the maintenance phase or who failed to clear their infection during the induction phase. The average percentage of patients with greater than or equal to 1 culture was lower in the oteseconazole group vs the fluconazole and placebo group (10.3% vs 42.9%, respectively).

The most frequently reported adverse events were headache (7.4%) and nausea (3.6%). One patient discontinued therapy because of allergic dermatitis. Because of the risk of embryo-fetal toxicity, oteseconazole is contraindicated in women of reproductive potential and in women who are pregnant or lactating. Medication administration in conjunction with a high-fat, high-calorie meal increased concentrations, but no significant differences were observed with a low- fat, low-calorie meal.

The oteseconazole-only dosage regimen is initiated as a 600-mg capsule on day 1 and 450 mg on day 2, each as a single dose. The next dose is administered on day 14 as a 150-mg capsule once weekly for 11 weeks.

The fluconazole/oteseconazole dosage regimen is initiated with fluconazole 150 mg orally on days 1, 4, and 7, followed by oteseconazole 150 mg once daily for 7 days, starting on day 14 through day 20. After day 20, the next oteseconazole dose is administered on day 28 as a 150-mg capsule once weekly for 11 weeks. Oteseconazole must be taken with food.

FDA approves Mycovia Pharmaceuticals’ VIVJOA (oteseconazole), the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). News release. Mycovia Pharmaceuticals; April 28, 2022. Accessed July 12, 2022. 

https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf

Vivjoa. Prescribing information. Mycovia Pharmaceuticals Inc; 2022. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215888s000lbl.pdf

A study of oral oteseconazole for the treatment of patients with recurrent vaginal candidiasis (yeast infection)(VIOLET). ClinicalTrails.gov. Updated April 6, 2022. Accessed July 12, 2022. 

https://clinicaltrials.gov/ct2/show/NCT03562156

A study of oral oteseconazole (VT-1161) for the treatment of patients with recurrent vaginal candidiasis (yeast infection) (VIOLET). ClinicalTrials.gov. Updated December 20, 2021. Accessed July 12, 2022. 

https://clinicaltrials.gov/ct2/show/NCT03561701

Study of oral oteseconazole (VT-1161) for acute yeast infections in patients with recurrent yeast infections (ultraVIOLET). ClinicalTrials.gov. Updated February 4, 2022. Accessed July 12, 2022. 

https://clinicaltrials.gov/ct2/show/NCT03840616

Oteseconazole is a treatment option for those living with a previously unmet medical need.

Vivjoa Approved for Recurrent Vulvovaginal Candidiasis

Director, International Drug Information Center

Diarrhea is a common adverse effect of antibiotics, affecting 11% to 40% of children treated with broad-spectrum antibiotics.

 Antibiotic-associated diarrhea (AAD) may occur when anti biotics disrupt the normal balance of the gut flora, causing harmful bacteria to multiply and destroy the gut microflora.

 Probiotics restore the natural balance of gut flora through the introduction of nonpathogenic bacterial or yeast microbiota and have been used in clinical trials and in practice to manage AAD in children.

Probiotics are generally well tolerated in healthy children, with minor adverse effects being dyspepsia, abdominal pain, nausea, and bloating.

 Probiotics should be avoided in children who are immunocompromised or severely debilitated.

 Likewise, probiotics must be used with caution in specific populations such as premature infants, critically ill patients, and patients with a central venous catheter, cardiac valvular disease, and short-gut syndrome.

 Although evidence supporting a clinically meaningful interaction between probiotics and antibiotics is lacking, the use of antibiotics could theoretically eradicate the microorganisms contained in the probiotics. Therefore, it has been suggested to space the administration of probiotics from antibiotics by 2 hours.

Because antibiotics are commonly used in the pediatric population, we sought to examine the evidence concerning the use of probiotics for the prevention of pediatric AAD. After applying search criteria, 7 relevant articles were identified, which are summarized below.

Shan et al described an open label, randomized, controlled trial involving 333 hospitalized children who were being treated with intravenous antibiotics.

 The study’s objective included an assessment of the efficacy of 

, dosed at 500 mg per day, for the prevention of AAD. Patients were followed during and 2 weeks after antibiotic therapy. The primary outcomes related to the prevention of AAD were the frequency and duration of AAD. In this study, the use of 

 resulted in statistically significant fewer occurrences of AAD. The investigators concluded that using 

 was effective for the prevention of AAD in children.

Georgieva et al described a randomized, controlled study that examined the efficacy of 

 In this study, 100 hospitalized children aged 3 to 12 years were randomly assigned to receive a probiotic tablet containing 1 × 10

 or placebo once daily during the antibiotic treatment period and for an additional 7 days. The primary study end point was the incidence of diarrhea during and up to 21 days post antibiotic treatment. The investigators found no statistically significant difference between the 2 groups but noted that because of the low incidence of AAD in both groups, no conclusion can be made about the efficacy of 

Fox et al described a randomized, double-blind, placebo-controlled study that examined the efficacy of a yogurt containing probiotics (

) for the prevention of AAD.9 In this study, 72 outpatients aged 1 to 12 years were randomly assigned to receive active yogurt or pasteurized yogurt (placebo) for the duration of their antibiotic treatment. The primary outcome was stool frequency and consistency. There were significantly fewer occurrences of diarrhea in the children who were given the probiotic-rich yogurt as compared with those receiving placebo. Also, more adverse events, including abdominal pain, loss of appetite, and nausea, were reported in the placebo group compared with the active group. The investigators concluded that the specific probiotic-rich yogurt used in the trial was an effective intervention for reducing the incidence of antibiotic-associated gastrointestinal disturbance in children.

Olek et al described a randomized, double-blind, placebo-controlled study that examined the efficacy of probiotics for the prevention of AAD in 438 outpatient children aged 1 to 11 years.

 Patients were assigned to receive a probiotic capsule containing 1 × 10

 or placebo once daily for the duration of antibiotic therapy and for 1 week after completion of treatment. The primary outcome was the incidence of antibiotic-associated loose/watery stools; the investigators found no statistically significant differences between the groups regarding this outcome. Furthermore, the incidence of children with at least 1 adverse event was significantly higher in the placebo group compared with the probiotic group. The investigators concluded that there was no beneficial effect of 

Kołodziej and Szajewska assessed the efficacy of 

 for the prevention of diarrhea and AAD in hospitalized children.

 The investigators randomly assigned 250 children younger than 18 years to receive 

 CFU or placebo twice daily for the duration of antibiotic treatment. Primary outcome measures were the occurrences of diarrhea and AAD. The investigators found no statistically significant differences between the 2 groups in the primary outcome measures. Additionally, there were no statistically significant differences in adverse effects. The investigators concluded that the study provided no evidence to support the use of 

Wronowski et al described a prospective, randomized, double-blind, placebo-controlled study in a pediatric hospital.12 In this study, 156 children aged 1 to 18 years were randomly assigned to receive 100-mg bovine lactoferrin or placebo twice daily for the duration of antibiotic therapy. The primary outcome was the occurrence of AAD during treatment and up to 2 weeks after antibiotic therapy. The investigators found no statistically significant benefit for the probiotic and concluded that bovine lactoferrin was not effective for the prevention of AAD.

Esposito et al described a placebo-controlled study designed to evaluate the effectiveness of 

 for the prevention of AAD in children receiving antibiotic therapy postoperatively.13 The study consisted of 3 groups (probiotic, no treatment, and placebo), with 30 boys in each group. The overall incidence of AAD was statistically significantly lower in the probiotic group compared with the other groups. Also, the duration of AAD was statistically significantly longer in the control groups than the probiotic group. The investigators concluded that the use of 

 significantly reduced the incidence and duration of AAD in children.

Clinical trials evaluating the use of probiotics for the prevention of AAD in children yielded varying results. A systematic review that assessed the results of 33 randomized, controlled studies concluded that probiotics produced

a moderate reduction in the incidence of pediatric AAD, with a larger effect noted with high-dose probiotics (≥ 5 billion CFUs/day).1 Furthermore, probiotics reduced the duration of diarrhea by almost 1 day. Among the various probiotics evaluated, 

 (eg, Florastor) at 5 to 40 billion CFUs per day appeared to be most appropriate for preventing AAD in children. The authors of the systematic review also stated that it is pre- mature to draw firm conclusions about other probiotic agents.

Notably, there does not seem to be a consensus concerning the use of probiotics to prevent AAD in children as a standard of care. When making recommendations concerning the use of probiotics, pharmacists should follow evidence-based practices.

Guo Q, Goldenberg JZ, Humphrey C, El Dib R, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. 

. 2019;4(4):CD004827. doi:10.1002/14651858.CD004827.pub5

Schrezenmeir J, de Vrese M. Probiotics, prebiotics, and synbiotics—approaching a definition. 

. 2001;73(suppl 2):361S-364S. doi:10.1093/ajcn/73.2.361s

Probiotics. Natural Medicines. Updated March 10, 2022. Accessed May 31, 2022. 

Salminen MK, Rautelin H, Tynkkynen S, et al. Lactobacillus bacteremia, clinical significance, and patient outcome, with special focus on probiotic 

Hojsak I, Fabiano V, Pop TL, et al. Guidance on the use of probiotics in clinical practice in children with selected clinical conditions and in specific vulnerable groups. 

. 2018;107(6):927-937. doi:10.1111/apa.14270

. 2010;67(6):449-458. doi:10.2146/ajhp090168

​​Shan LS, Hou P, Wang ZJ, et al. Prevention and treatment of diarrhoea with 

 in children with acute lower respiratory tract infections. 

. 2013;4(4):329-334. doi:10.3920/BM2013.0008

Georgieva M, Pancheva R, Rasheva N, Usheva N, Ivanova L, Koleva K. Use of the probiotic 

 DSM 17938 in the prevention of antibiotic-associated infections in hospitalized Bulgarian children: a randomized, controlled trial. 

. 2015;21(4):895-900. doi:10.5272/jimab.2015214.895

Fox MJ, Ahuja KD, Robertson IK, Ball MJ, Eri RD. Can probiotic yogurt prevent diarrhoea in children on antibiotics? A double-blind, randomised, placebo-controlled study. 

. 2015;5(1):e006474. doi:10.1136/bmjopen-2014-006474

Olek A, Woynarowski M, Ahrén IL, et al. Efficacy and safety of 

 DSM 9843 (LP299V) in the prevention of antibiotic-associated gastrointestinal symptoms in children-randomized: double-blind, placebo-controlled study. 

. 2017;186:82-86. doi:10.1016/j.jpeds.2017.03.047

DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: a randomized clinical trial. 

. 2019;25(6):699-704. doi:10.1016/j.cmi.2018.08.017

Wronowski MF, Kotowska M, Banasiuk M, Kotowski A, Kuzmicka W, Albrecht P. Bovine lactoferrin in the prevention of antibiotic-associated diarrhea in children: a randomized clinical trial. 

. 2021;9:675606. doi:10.3389/fped.2021.675606

Esposito C, Roberti A, Turrà F, et al. Frequency of antibiotic-associated diarrhea and related complications in pediatric patients who underwent hypospadias repair: a comparative study using probiotics vs placebo. 

. 2018;10(2):323-328. doi:10.1007/s12602-017-9324-4

Evidence of the relationship between probiotics and antibiotics is lacking.

Probiotics for the Prevention of Pediatric Antibiotic-Associated Diarrhea

 Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

The agency had accepted the supplemental biologics license application (sBLA) in July 2022, and the company had indicated that the Prescription Drug User Fee Act date (PDUFA) action date was during the fourth quarter of the 2022.

“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, said in a press release. “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”

Enhertu is an engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

About 80% to 85% of those new cases were previously considered to be HER2-negative subtype, which means the tumors do not overexpress, or make too many copies of the HER2 protein. Of that proportion of breast cancer diagnoses, about 60% of patients previously classified as having HER2-negative subtype can now be considered as HER2-low and are now eligible to receive Enhertu. Prior to today’s approval, HER2-low patients received endocrine therapy or chemotherapy.

, a randomized, multicenter, open label clinical trial that enrolled 557 adult patients with unresectable or metastatic HER2-low breast cancer. The trial included two cohorts: 494 hormone receptor positive patients and 63 hormone receptor negative patients. The results showed improvement in both progression-free survival and overall survival in people with unresectable or metastatic HER2-low breast cancer.

This article originally appeared on Formulary Watch.

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

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