FDA Roundup: Agency Highlights from July 2024

FDA Approval Marks Epysqli as Second Soliris Biosimilar

FDA Roundup: Agency Highlights from July 2024 / Grandbrothers - stock.adobe.com

The FDA approved the Biologics License Application for eculizumab-aagh (Epysqli) as a biosimilar to eculizumab (Soliris). The biosimilar has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. The company noted that the medication is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome.

With FDA Approval, Vonoprozan Offers Options for Nonerosive GERD

The FDA approved vonoprazan (Voquenza) 10 mg tablets for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. This represents the third FDA approval for vonoprazan; the drug is also approved to treat erosive esophagitis or erosive GERD and Helicobacter pylori infection, in combination with antibiotics.

Novo Nordisk Once-Weekly Insulin Faces Approval Setback With CRL

The FDA issued a Complete Response Letter (CRL) to Novo Nordisk for the company’s once-weekly basal insulin icodec for the treatment of diabetes. In the CRL, the agency said it requires additional details on the manufacturing process as well as the drug’s indication for type 1 diabetes (T1D) before it can complete its review of a Biologics License Application. Novo Nordisk said it will not be able to provide this information until next year.

FDA Approves Roflumilast Cream 0.15% for Atopic Dermatitis in Pediatric, Adult Patients

The FDA approved the supplemental new drug application (sNDA) for roflumilast cream, 0.15% (Zoryve) for the treatment of mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged 6 years and older. The cream provides rapid disease clearance and significant reduction in itch to patients and has been specifically formulated for long-term disease control.

FDA Approves Donanemab (Kisunla) For Early Symptomatic Alzheimer Disease

The FDA approved donanemab-azbt (Kisunla), the first and only amyloid plaque-targeting therapy for early symptomatic Alzheimer disease. Donanemab-azbt “uses a limited-duration treatment regimen based on amyloid plaque removal,” according to a news release from manufacturer Eli Lilly. The drug was granted Fast Track Review, Priority Review, and Breakthrough Therapy designations.

FDA, FTC Issue Warnings to Companies Selling Copycat Food Products Containing Delta-8 THC

Warning letters have been issued to 5 companies illegally selling copycat food items containing delta-8 THC, in violation of the Federal Food, Drug, and Cosmetic Act, according to the FDA. These letters are part of a joint effort from the FDA and the Federal Trade Commission (FTC) “to take action against companies selling illegal copycat food products containing delta-8 THC,” per an FDA news release. The agencies previously worked together in June 2023 to distribute warning letters for 6 other companies selling edible food products containing delta-8 THC “in packaging that could easily be confused for foods sold by popular national brands.”

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