EMA grants Orphan Drug Designations for Edgewise’s sevasemten to treat Becker

Edgewise Therapeutics announced that the European Medicines Agency EMA has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy and for the treatment of Duchenne muscular dystrophy Duchenne . Sevasemten is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage. Sevasemten is currently in late-stage clinical trials for individuals with Becker and is also being studied in Duchenne. “Receiving Orphan Drug designation in the U.S. and now in Europe highlights alignment across regions on the urgent and critical need for new and better therapeutic options for people living with Becker or Duchenne,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “We are focused on advancing these muscle-targeted therapeutics as quickly as possible through clinical development for these communities.”