Patient deaths, testing concerns and “weak arguments.” Those are just a few of the issues the FDA had with Sarepta Therapeutics’s recent drug application, according to new documents released this week.
The FDA offered a rare peek at its decision-making process Wednesday, releasing documents related to its initial rejection and later approval of Sarepta’s (Nasdaq: SRPT) rare disease drug Vyondys 53.
Such documents are usually not available to the public and are exempt from public records requests, except in cases when a drug is first rejected and later approved.
Sarepta CEO Doug Ingram previously declined to release the rejection letter. A company spokesperson said that concerns noted in the rejection letter are not unique to Sarepta’s drugs.
