Avidity announces accelerated approval regulatory pathway for Del-Brax

Avidity Biosciences (RNA) announced the accelerated approval regulatory pathway in the United States is open for delpacibart braxlosiran, del-brax, in the treatment of facioscapulohumeral muscular dystrophy, FSHD. Additionally, the Company announced that it has initiated its global, confirmatory, Phase 3 FORWARD study intended to support a subsequent full approval package for del-brax for people living with FSHD in the U.S. and additional countries around the world. “Our regulatory and clinical development progress announced today reflect our continued leadership in rare neuromuscular diseases and bring us a step closer to providing a treatment option to the FSHD community that could meaningfully impact their disease,” said Sarah Boyce, president and chief executive officer at Avidity. “We have confirmed with the FDA that the accelerated approval pathway is open for del-brax. In addition, we have initiated our global confirmatory Phase 3 study intended to support our global approval strategy for del-brax.”