Drug Topics staff

The FDA has granted emergency use authorization (EUA) to Johnson & Johnson for its COVID-19 vaccine following an advisory panel meeting on Friday.

The vaccine, named Ad26.COV2.S, is the first single-dose COVID-19 vaccine and the third vaccine to be authorized in the US for the virus.

The EUA is based on the phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.

As part of its authorization, the FDA noted it is mandatory for Janssen Biotech and vaccination providers to report the following to the Vaccines Adverse Event Reporting System for Janssen COVID-19 Vaccine: serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA, through our open and transparent scientific review process, has now authorized 3 COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

 for more information on the vaccine’s efficacy and safety data. 

1. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. News release. FDA; February 27, 2021. Accessed February 27, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

Articles

The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.

FDA Grants Emergency Use Authorization to Third COVID-19 Vaccine

Several drug approvals made headlines this year, ranging from novel treatments to exciting new indications for existing drug therapies.

 coronavirus disease 2019 (COVID-19) vaccines, both of which were granted emergency use authorization by the FDA in December. In another historic feat, 

remdesivir (Veklury; Gilead) scored an approval

 from the agency as the first drug treatment for COVID-19 on October 22. Remdesivir is indicated for use in hospitalized adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms.

Apart from record-breaking COVID-19 approvals, there were plenty of other noteworthy drug approvals from 2020.

Here are some of the top-read FDA approvals covered by 

10. FDA Approves Oliceridine for Pain Management in Hospitals, Controlled Clinical Settings

Oliceridine (Olinvyk; Trevena Inc), which was approved in August, is an opioid agonist for the management of pain that is severe enough to require intravenous opioid and when alternative treatments are ineffective.

In September, the FDA approved 2 additional doses of dulaglutide (Trulicity; Eli Lilly) for the treatment of type 2 diabetes. Approval of the 3.0 mg and 4.5 mg doses was based on favorable results in regard to A1C and body weight reduction, stemming from the phase 2 AWARD-11 clinical trial comparing the additional doses with 1.5 mg doses in individuals with type 2 diabetes.

8. FDA OKs New Indication for Esketamine Nasal Spray

In August, esketamine (Spravato; Janssen) CIII nasal spray became the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

7. FDA Approves CBD Treatment for Seizures in Rare Genetic Disease

The FDA approved cannabidiol (CBD) (Epidiolex; Greenwich Biosciences Inc) oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.

The latest indication is only the third approval for CBD, and follows the FDA’s recent draft guidance for conducting CBD research to facilitate and support safe and effective study results.

6. FDA OKs First Treatment for Ebola Virus

Regeneron’s Inmazeb became the first FDA-approved treatment 

 (Ebola virus) infection in adult and pediatric patients when it was granted approval in October. The monoclonal antibody mixture is composed of atoltivimiab, maftivimab, and odesivimab-ebgn.

5. FDA Approves Mepolizumab for Hypereosinophilic Syndrome

The FDA approved mepolizumab (Nucala; GlaxoSmithKline) as the first biologic treatment for hypereosinophilic syndrome in adult and pediatric patients aged 12 and older.

4. FDA Approves Tofacitinib for Juvenile Idiopathic Arthritis

The FDA approved tofacitinib (Xeljanz; Pfizer) for the treatment of children and adolescents 2 years of age and older with active polyarticular course juvenile idiopathic arthritis, making it the first and only Janus kinase inhibitor approved in the US for this indication.

3. FDA Approves Baloxavir Marboxil for Post-Exposure Prophylaxis of Influenza

Baloxavir marboxil (Xofluza; Genentech) received FDA approval for the prevention of influenza in individuals aged 12 years of age and older following contact with a person infected with the fly, making it the first single-dose influenza medicine approved for post-exposure prophylaxis. 

2. FDA Approves Dupilumab for Atopic Dermatitis in Children

In May, dupilumab (Dupixent; Sanofi and Regeneron) received approval for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years old. With this approval, dupilumab is the only biologic medicine approved for this patient population.

1. FDA Approves Ozanimod for Relapsing Multiple Sclerosis

The FDA granted approval to ozanimod (Zeposia; Bristol Myers Squibb) in March for the treatment of relapsing multiple sclerosis. The approval includes indicated uses for clinically isolated syndrome, relapsing-remitting disease, and active secondary disease.

Here are some of the top-read FDA approvals covered by Drug Topics® from this year.

Top FDA Approvals of 2020

The coronavirus disease 2019 (COVID-19) pandemic has dominated headlines and remained a centerpiece of much of our coverage this year. However, there were plenty of other news topics that resonated with readers––from product recalls and FDA approvals to new and exciting medical research.

As we look back at 2020 and ahead to 2021, the 

® team rounded up some of our top-read articles from the last year.

10. New Diabetes Medications, Technologies You Should Know

With new drugs and technologies available, pharmacists are at the forefront of the effort to educate patients and health care professionals about diabetes treatments, monitoring options, and pipeline drugs.

9. USPSTF Issues Draft Recommendation on Vitamin D Screening in Adults

The US Preventive Services Task Force concluded that the current evidence is insufficient to make a recommendation for or against vitamin D deficiency screening in asymptomatic adults.

8. Psychedelic Medicines for Pain Go Mainstream

This article, published in July, provides an overview of certain illicit drugs being researched as potential alternatives to opioids in pain management. Substances including cannabis, psilocybin, and kratom are discussed.

7. All Pharmacists Now Authorized to Administer Childhood Vaccines

In August, the Department of Health and Human Services authorized all state-licensed pharmacists to order and administer childhood vaccinations amid the COVID-19 pandemic.

6. Premature Testing More Likely to Result in False Negative for COVID-19

In June, a Johns Hopkins research team of investigators suggested that testing infected individuals too early for COVID-19 may result in a false negative, even though they may test positive for the virus later.

5. Study Suggests Digestive Symptoms May Be Associated with COVID-19

Early on in the pandemic, a study from China reported that approximately half of patients in the Wuhan outbreak presented with digestive symptoms as their chief complaint. The findings suggested that digestive symptoms, such as diarrhea, could be a presenting feature of COVID-19.

4. 8 Things to Know About the Spanish Influenza Pandemic of 1918-1919

As the world grappled with the COVID-19 pandemic this year, our 2018 article on the Spanish flu pandemic resurfaced among readers. Take a look back at one of the worst pandemics in global history with this article.

3. FDA Approves Oliceridine for Pain Management in Hospitals, Controlled Settings

In August, the FDA approved olicieridine (Olinvyk; Trevena Inc), an opioid agonist for the management of pain that is severe enough to require an intravenous opioid and when alternative treatments were ineffective.

2. First Big Metformin Product Recalled, More on the Way

In more big news from the year, an FDA investigation identified elevated levels of the carcinogenic ingredient N-nitrosodimethylamine in certain extended-release (ER) metformin products, spurring a number of product recalls. 

In May, Apotex Corp and Amneal Pharmaceuticals both issued voluntary recalls of their metformin hydrochloride ER tablets.

COVID-19–related news dominated headlines for many reasons, but this article on the virus’ effect on shingles was the top-read piece on the 

The article discusses the effect of coronavirus-related stress on the human body and the potential triggering effects for individuals with underlying health conditions.

The Drug Topics® team rounded up some of our top-read articles from the last year. 