In a press release on July 28, Sarepta Therapeutics of Cambridge, Massachusetts, announced that it had been cleared by the FDA to resume shipments of the drug delandistrogene moxeparvovec (brand name ELEVIDYS) after the agency conducted a safety review of the product.

“Last week, at the suggestion of FDA, Sarepta made the difficult decision to pause shipments of ELEVIDYS to provide the FDA with an opportunity to complete a review of available safety information," the company said in its press release announcing the decision. "We are very pleased that FDA chose to rapidly and comprehensively complete that review and to recommend that we remove our voluntary pause and resume shipment of ELEVIDYS for ambulatory patients."

Sarepta CEO Doug Ingram noted that the company looks "forward to working collaboratively with the FDA to complete the safety label update for ELEVIDYS and to discussing the approach to risk-mitigation for non-ambulatory patients, who remain on pause pending the outcome of those discussions.” 

The company says that ELEVIDYS is a single-dose "gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy.

The disease largely affects boys, beginning around age six, according to the Cleveland Clinic. It weakens muscles, including the heart, and progresses rapidly. Symptoms include muscle weakness, fatigue, loss of muscle mass, and stiff joints, among others. 

There is no cure. 

Read more in the press release from Sarepta