Anvisa approves Duvyzat for Duchenne muscular dystrophy

Brazil’s National Health Surveillance Agency (Anvisa) has approved the registration of Duvyzat (givinostate), an oral medication for the treatment of Duchenne muscular dystrophy (DMD). Developed by Multicare Pharmaceuticals, the drug is an oral solution intended for patients aged 6 years and older, to be used in conjunction with corticosteroids.

Clinical studies indicate that the medication can slow the loss of motor capacity and preserve muscle function compared to standard corticosteroid treatments alone. Duchenne muscular dystrophy is a rare, progressive genetic disorder that primarily affects boys, leading to muscle weakness that can eventually impact respiratory and cardiac functions.

While the registration allows for commercialization in Brazil, immediate availability in pharmacies or incorporation into the Unified Health System (SUS) is not guaranteed, as these steps require further commercial decisions, pricing definitions, and specific health system evaluations.