FDA grants Edgewise fast track designation for EDG-5506 to treat Duchenne

Edgewise Therapeutics announced that the U.S. Food and Drug Administration FDA has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. 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 . The FDA previously granted EDG-5506 Orphan Drug Designation ODD for the treatment of Duchenne and Becker, Rare Pediatric Disease Designation RPDD for the treatment of Duchenne, and Fast Track designation for the treatment of Becker. “Every day is important for individuals living with Duchenne and their families, and we are pleased that the FDA granted Fast Track designation,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “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.”