Datapoint: Sarepta Scores Label Expansion for Elevidys
The FDA last week expanded the label for Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl) to include all Duchenne muscular dystrophy (DMD) patients aged 4 and older. The drug — the first gene therapy available to treat DMD — received accelerated approval in 2023, but was only available to ambulatory male patients aged 4 to 5. “The initial approval of ELEVIDYS was a significant milestone, and the expanded indication means clinicians now have a treatment option for the great majority of boys and young men living with Duchenne,” Dr. Jerry Mendell, the co-inventor of Elevidys and senior advisor, medical affairs at Sarepta said in a statement. Elevidys, which is administered as a one-time intravenous infusion, currently holds covered or better status for 47% of all insured lives under the medical benefit.
SOURCE: MMIT Analytics, as of 6/24/24
