Important Update: Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label

CureDuchenne is sharing a community letter from Sarepta announcing a strategic company restructuring and pipeline prioritization plan.

Additionally, Sarepta shared that the U.S. FDA has requested and Sarepta has agreed to include a black box warning in the ELEVIDYS label, resolving any material issues with the ambulant population indication. Sarepta has completed an Expert Committee on a protocol for the use of additional prophylactic immunosuppression for non-ambulant patients and will submit the protocol to FDA imminently and discuss the pathway to resume shipment of ELEVIDYS for non-ambulant patients. 

Read Sarepta’s Community Letter and Press Release to learn more about what this means for your family.