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Edgewise Therapeutics

Edgewise Therapeutics: FDA Fast Track for EDG-5506

February 13, 2024

Edgewise Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy.

What is EDG-5506?

EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy (Becker). 

“Every day is important for individuals living with Duchenne and their families, and we are pleased that the FDA granted Fast Track designation. Our roster of regulatory designations granted to EDG-5506 highlights the urgent and critical need for new and better therapeutic options for people living with these rare and life-threatening muscle disorders.” 

Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise

The FDA previously granted EDG-5506 Orphan Drug designation for the treatment of Duchenne and Becker, Rare Pediatric Disease designation for the treatment of Duchenne, and Fast Track designation for the treatment of Becker. 

What is the FDA Fast Track Program?

It is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and fill an unmet medical need. The designation is granted to therapeutics that offer the potential to meaningfully impact survival, day-to-day functioning, or, if left untreated, the progression of the condition. Therapeutics that receive this designation receive important benefits that include more frequent meetings with the FDA to discuss the development of the drug candidate.

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