The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy
Shots:
- The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA)
- Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024
- Evrysdi, an SMN2 splicing modifier, treats SMA caused by chromosome 5q mutations leading to SMN protein deficiency, & can be administered as a liquid or a tablet
Ref: Roche | Image: Roche| Press Release
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