FDA’s label changes to Sarepta’s Elevidys address physician concerns

Nearly a year and a half after Sarepta’s Elevidys gained full FDA approval for Duchenne muscular dystrophy, the agency is updating the gene therapy’s label with restrictions and warnings that address concerns physicians have voiced from the start.

The new label for the  Sarepta Therapeutics Inc. (NASDAQ:SRPT) therapy narrows the eligible patient population to ambulatory Duchenne muscular dystrophy patients aged four years or older with a confirmed mutation in the dystrophin gene. The change excludes non-ambulatory patients, who are less likely to benefit and more likely to be harmed by the AAV gene therapy...