SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has approved a New Drug Application or NDA for an Evrysdi (risdiplam) tablet for people living with spinal muscular atrophy or SMA. Evrysdi is the only non-invasive disease-modifying treatment for spinal muscular atrophy. The 5 mg Evrysdi tablet can either be swallowed whole or dispersed in water.
As part of the label extension, the Evrysdi prescribing information has been updated to include guidance on tablet administration and storage.
Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.
The new tablet, expected to be available in the coming weeks, is suitable for people 2 years of age or older who weigh more than 44 lbs (20 kgs).
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