FDA's Jenkins says Sarepta's path is not a model

The path that led to approval of Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) is "not a good model for other development programs," John Jenkins, director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research (CDER), said Tuesday.

In slides presented at a National Organization for Rare Diseases (NORD) meeting, Jenkins said that a "poorly planned and executed development program for a rare disease misuses valuable patient resources and serves to delay obtaining the knowledge required to understand the benefits and risks of a drug to support regulatory review and approval." ...