Sarepta Therapeutics Submits Efficacy Supplement to Expand the ELEVIDYS Label to include Duchenne Muscular Dystrophy Patients without Restriction to Age or Ambulatory Status
The supplement was submitted to the U.S. Food and Drug Administration (FDA) with a request for Priority Review.
- The supplement was submitted to the U.S. Food and Drug Administration (FDA) with a request for Priority Review.
- An efficacy supplement is a submitted request for a proposed change to an approved product’s labeling, including adding or modifying an indication previously filed with the FDA.
- Sarepta has also completed the EMBARK postmarketing requirement (PMR) and submitted the PMR to FDA requesting conversion from accelerated approval to traditional approval.
- Roche is responsible for regulatory approvals and bringing ELEVIDYS to patients across the rest of the world.