Roche’s Evrysdi tablet approved by EC for SMA

Roche (RHHBY) announced that the European Commission, EC, has approved a label extension for Evrysdi to include a new, room-temperature stable tablet for people living with spinal muscular atrophy, SMA. The 5mg tablet, which can either be swallowed whole or dispersed in water, can be taken with or without food and does not require refrigeration, when stored at room temperature. Administered at home, Evrysdi is the only non-invasive disease modifying treatment available for people living with SMA. “The new Evrysdi tablet with its flexible administration represents progress toward more versatile SMA disease management,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche. “With over 18,000 people treated to date, Evrysdi’s proven efficacy, safety and convenience has significantly improved the course of disease for people living with SMA.”