Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand.

In a surprising reversal, Sarepta on Monday said it will pause all shipments of its Duchenne muscular dystrophy gene therapy Elevidys in the U.S., effective at the end of business on July 22.

The FDA made the distribution suspension request Friday after multiple patient deaths, including two following treatment with Elevidys. More recently, Sarepta disclosed the death of a third patient who was given one of its gene therapies. That patient had received an investigational therapy for a different disease—limb-girdle muscular dystrophy (LGMD)—in a clinical trial.

Sarepta initially refused to play ball with the FDA's request, citing its own “comprehensive scientific interpretation of the data,” but it's now changing course.

In its Monday release, Sarepta said the pause will allow the company “the necessary time to respond to any requests for information” and to complete updating Elevidys’ safety labeling per an agreement with the FDA. The company is working with the FDA...