Roche’s Evrysdi tablet OKd by European Commission as first and only for Spinal Muscular Atrophy

Roche (RHHBY) has received European Commission approval for a new tablet formulation of Evrysdi (risdiplam), marking a significant advancement in Spinal Muscular Atrophy (SMA) treatment. The 5mg tablet, which can be swallowed whole or dispersed in water, offers room-temperature stability and doesn't require refrigeration. This new formulation maintains the same efficacy and safety as the original oral solution, as demonstrated in bioequivalence studies. Evrysdi, the only non-invasive disease-modifying SMA treatment, has treated over 18,000 patients globally. The tablet is approved for patients aged two years or older, weighing 20kg or more, who can swallow without a feeding tube. The original oral solution will remain available for patients requiring different doses or preferring that format.

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