FDA Probes Sarepta’s Gene Therapies After Third Patient Death

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from Sarepta Therapeutics Inc. should remain on the market.

Makary made the comments in an interview with Bloomberg News.

The FDA was already investigating two previous patient deaths involving the treatment, Elevidys. On Thursday, the company disclosed that a third patient had died in a clinical trial after getting a different gene therapy that uses a similar viral delivery method.

To contact the reporters on this story:
Fiona Rutherford in New York at frutherford@bloomberg.net;
Gerry Smith in New York ...