Vinay Prasad, chief of the Center for Biologics Evaluation and Research, will leave the Food and Drug Administration at the end of April, according to a March 11 announcement. The news follows recent controversy over the agency's handling of rare disease drug approvals and has led to significant stock movements among affected biotech companies.
The departure comes amid heightened attention on the FDA's decisions regarding cell and gene therapies for rare diseases. H.C. Wainwright said in a note that at least five such therapies might have been approved under previous FDA leadership. This issue has drawn political attention, with Wisconsin Senator Ron Johnson launching an investigation into recent denials, as reported by Bloomberg News.
Johnson criticized the FDA’s request for uniQure to conduct a sham surgery-controlled trial of its Huntington’s treatment AMT-130, calling it “bureaucratic idiocy.” There appears to be disagreement between uniQure and the FDA about how invasive this trial would be. UniQure Chief Medical Officer Walid Abi-Saab described it as a 10-12 hour surgery involving drilling holes in patients’ skulls, while Prasad said last week that it would require only “one to three nicks in the scalp.”
In related industry news, several obesity drug trials have produced mixed results. Roche and Zealand Pharma’s amylin analog did not perform as well as Eli Lilly’s eloralintide candidate. AbbVie reported nearly 10% weight loss at 13 weeks in a Phase 1 trial for its amylin analog, which analysts called competitive. Regeneron announced positive Phase 3 results for olatorepatide in China through its partnership with Hansoh. Novo Nordisk also reached an agreement with Hims & Hers to distribute its GLP-1 medicines via telehealth.
On the business side, experts report increased competition among biopharma companies seeking mergers and acquisitions due to fewer available targets.
