(CercleFinance.com) – Roche announces that the European Commission has approved the extension of its marketing authorization (MA) for Evrysdi in the European Union (EU) to infants under two months of age with spinal muscular atrophy (SMA).
This approval is based on interim data from the ongoing RAINBOWFISH trial showing that the majority of babies treated with Evrysdi were able to stand and walk within times typical of healthy babies at 12 months of treatment.
Evrysdi will thus be available to treat people of all ages with SMA in the EU. The only non-invasive treatment for this disease, it is approved in 100 countries with more than 11,000 patients treated worldwide.
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