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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

Related News:- Roche Reports P-III (IMforte) Trial Findings on Tecentriq Regimen as a 1L Maintenance Therapy for ES-SCLC

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