Roche (RHHBY) announced that the Food and Drug Administration has approved a New Drug Application for an Evrysdi tablet for people living with spinal muscular atrophy. “Evrysdi is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrysdi tablet can either be swallowed whole or dispersed in water,” the company stated. As part of the label extension, the Evrysdi prescribing information has been updated to include guidance on tablet administration and storage. The new tablet, expected to be available in the coming weeks, is suitable for people two years of age or older who weigh more than 20 kgs, the company added. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics (PTCT).
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on RHHBY:
- Roche initiated with an Equal Weight at Morgan Stanley
- Balanced Outlook on Roche Holding Amid Gazyva’s Promising Yet Uncertain Prospects
- Recursion Pharmaceuticals’ (RXRX) AI Approach to Drug Discovery Shows Progress
- Trump Trade: President advocates to close carried interest tax loophole
- Genentech publishes REGENCY trial data in the New England Journal of Medicine