FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA) - Pipelinereview

FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA) - Pipelinereview

– Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries – – Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution – – New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration – SOUTH SAN FRANCISCO, CA, USA I February 12, 2025 I Genentech, …

FDA Approves Genentech's Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

“Evrysdi has robust potential to modify the SMA disease trajectory, and has already been used to treat thousands of patients to date. This approval marks another significant step forward,” said Levi Garraway, M.D., Ph.D., Genentech’s Chief Medical Officer and Head of Global Product Development. “The Evrysdi tablet combines established efficacy with convenience, providing an additional flexible option for SMA management.” …