FDA approves Evrysdi as first and only tablet for SMA

The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) from Swiss pharma giant Roche’s (ROG: SIX) Genentech subsidiary for an Evrysdi (risdiplam) tablet for people living with spinal muscular atrophy (SMA).

The company noted that Evrysdi is the only non-invasive disease-modifying treatment for SMA. The 5mg Evrysdi tablet can either be swallowed whole or dispersed in water.

“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 Dr Levi Garraway, Genentech’s chief medical officer and head of global product development, adding: “The Evrysdi tablet combines established efficacy with convenience, providing an additional flexible option for SMA management.”