FDA Roundup: Pneumococcal Conjugate Vaccine, Ulcerative Colitis Treatment

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Check out important updates from the FDA for the week of June 17.

FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive

FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive / grandbrothers - stock.adobe.com

FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive / grandbrothers - stock.adobe.com

The FDA approved Merck’s Capvaxive (V116), Merck’s pneumococcal 21-valent conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older. Capvaxive specifically targets the serotypes responsible for a majority of cases of invasive pneumococcal disease.

It is approved for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B, as well as for active immunization for the prevention of pneumonia caused by S pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

FDA approval for Capvaxive was based on clinical data from the pivotal phase 3 STRIDE-3 trial (NCT05425732), which evaluated Capvaxive vs PCV20 in adults aged 18 years and older who had not received a previous pneumococcal vaccine. Additional data were provided by results from the phase 3 STRIDE-5 and STRIDE-6 clinical trials (NCT05526716, NCT05420961), which evaluated Capvaxive in both vaccine-naïve and vaccine-experienced adults.

“Complications from invasive pneumococcal disease can lead to hospitalization, organ damage, and even death,” said Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, and a member of Merck’s Scientific Advisory Committee. “Capvaxive is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”

READ MORE: What Can be Learned From the FDA Advisory Panel’s Meeting on MDMA?

FDA Approves Risankizumab-Rzaa for Treatment of Ulcerative Colitis

The FDA approved risankizumab-rzaa (Skyrizi) for the treatment of moderately to severely active ulcerative colitis in adults, AbbVie announced in a release.1 Skyrizi, the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease, is now approved for 4 indications across immune-mediated inflammatory diseases.

The approval was based on data from phase 3 trials: the INSPIRE study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of risankizumab 1200 mg IV administered every 4 weeks as induction therapy in subjects with moderately to severely active ulcerative colitis; and the Command Study, a multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis.

"When treating patients with ulcerative colitis, it's important to prioritize both early and sustained clinical remission as well as endoscopic improvement," Edward V. Loftus, Jr, MD, Maxine and Jack Zarrow Family Professor of Gastroenterology in the division of gastroenterology and hepatology at Mayo Clinic, said in a release.1 "This approval for Skyrizi is an important step toward addressing these treatment goals."

FDA Approved Expanded Useof Elevidys to Treat Duchenne Muscular Dystrophy in Patients Ages 4 and Above

The FDA approved a label expansion for delandistrogene moxeparvovec-rokl (elevidys) to treat Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. Elevidys was granted traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients.

In a release, Sarepta Therapeutics said that it plans to submit the results from the ENVISION study, a global, randomized, double-blind, placebo-controlled phase 3 trial of elevidys in non-ambulatory and older ambulatory individuals with Duchenne, to satisfy postmarketing reequipments set by the FDA.2

“Representing many years of dedicated research, development, investment and creative energy, the expansion of the elevidys label to treat Duchenne patients aged 4 and above, regardless of ambulatory status, is a defining moment for the Duchenne community,” Doug Ingram, president and CEO of Sarepta, said in a release.2 “Today also stands as a watershed occasion for the promise of gene therapy and a win for science.”

READ MORE: FDA Updates Resource Center

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References
1. U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease. News Release. AbbVie. June 18, 2024. Accessed June 21, 2024. https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease
2. Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients Ages 4 and Above. News Release. Sarepta. June 20, 2024. Accessed June 21, 2024. https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-expanded-us-fda-approval-elevidys
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