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 2024Evrysdi, an SMN2 splicing modifier, treats SMA caused by…

ByRidhi RastogiJune 5, 2025

INSIGHTS+

Disease of the Month – Spinal Muscular Atrophy

Shots:To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research Continuing the series for the disease of the month, PharmaShots brings this month a summary of Spinal Muscular Atrophy, a genetic neuromuscular disease that affects…

BySaurabh ChaubeyAugust 17, 2023

VIEWPOINTS

Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New SPINRAZA (nusinersen) Long-Term Data in SMA

Shots:Kathleen spoke about new long-term SPINRAZA (nusinersen) data presented at the 3rd International Scientific CongressShe then explained the new findings from individuals with infantile-onset SMA who were treated with SPINRAZA in the pivotal ENDEAR study followed by the long-term extension SHINE study for up to 7 yearsThe interview also discusses Biogen’s advances…

BySenior EditorAugust 7, 2023

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Disease of the Month – Spinal Muscular Atrophy

Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New SPINRAZA (nusinersen) Long-Term Data in SMA

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