Anvisa approves Evrysdi Go tablet for spinal muscular atrophy

Brazil’s National Health Surveillance Agency (Anvisa) has authorized the registration of Evrysdi Go (risdiplam) for the treatment of spinal muscular atrophy (SMA) 5q. The approval, formalized via Resolution No. 4.244/2026, covers adults and children aged 2 years and older who weigh at least 20 kilograms and are diagnosed with types 1, 2, or 3 of the disease.

A significant feature of this new registration is the presentation of the medication in coated tablets. Unlike previous versions that required professional reconstitution and constant refrigeration, these tablets can be swallowed with water or dissolved in non-chlorinated water. This formulation can be stored at room temperature, which simplifies administration for caregivers and reduces risks associated with the cold chain during transport.

SMA is a rare genetic neurodegenerative disorder caused by a deficiency in the SMN protein, leading to the progressive loss of motor neurons. Risdiplam works by increasing the production of the SMN protein through the SMN2 gene, helping to preserve motor neurons and slow disease progression.