Sarepta Therapeutics and Clinigen Group have initiated a managed access program (MAP) for eteplirsen in certain geographies to treat Duchenne Muscular Dystrophy patients amenable to exon 51 skipping.
The MAP (also known as an early/expanded access, or named patient program) provides a mechanism through which physicians can legally and ethically prescribe eteplirsen to patients who meet pre-specified medical criteria and where funding can be secured. The program is being initially launched in select countries within Europe, North America and South America for certain patients where eteplirsen is not currently approved. Sarepta plans to expand the program to include more countries over time. It will be administered by Clinigen Group Idis Managed Access division.