FDA Biologics Chief to Depart After Blocking Sarepta’s Elevidys Approval
Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will resign at the end of April after a tenure marked by high-profile regulatory disputes. He reversed decisions on multiple gene therapies and explicitly challenged approval of Sarepta Therapeutics’ Duchenne muscular dystrophy treatment Elevidys.
1. Prasad Announces Departure
Dr. Vinay Prasad confirmed his resignation as head of the FDA’s Center for Biologics Evaluation and Research effective April 30, closing a tenure that began in May 2025. His departure follows ongoing debate over trial requirements for gene therapies and vaccines.
2. Regulatory Reversals and Controversies
During his time at CBER, Prasad ordered reversals of rare-disease drug decisions and refused to consider certain flu shot applications. His scrutiny extended to Sarepta’s Elevidys, arguing that evidence was insufficient to support marketing approval for the Duchenne muscular dystrophy therapy.
3. Potential Impact on Sarepta Therapeutics
With Prasad’s exit, Sarepta may face a more favorable review environment for Elevidys as the FDA seeks to demonstrate regulatory flexibility. Industry observers anticipate that a new director may revisit requirements for accelerated approvals in rare-disease treatments.