Sarepta’s Elevidys to Remain on Market With New FDA Warning

Sarepta Therapeutics Inc.’s controversial gene therapy for a rare muscle condition will remain available in the US with a strict new warning about potentially deadly liver injuries, a regulatory decision that removes the risk it would be pulled from the market.

The Food and Drug Administration said Friday it was adding a boxed warning, the agency’s most severe form of caution, to Elevidys. The agency also said use of the gene therapy should be limited to children with Duchenne muscular dystrophy who are four years of age and older, and can still walk.