The Duvyzat approval came nine months after the FDA greenlit Sarepta Therapeutics’ Elevidys under the accelerated approval pathway, the first gene therapy to treat DMD.
Muscular Dystrophy Association gears up for Holiday Retail Campaign
Sarepta Therapeutics’ Elevidys failed to meet its primary endpoint in a Phase 3 trial, shortly after the FDA granted it accelerated approval for Duchenne muscular dystrophy.
Muscular Dystrophy Association launches 30 Days of Strength campaign