Roche announced that the European Commission has approved the extension of the Evrysdi European Union marketing authorization to include infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months. Interim data from the ongoing RAINBOWFISH trial in pre-symptomatic babies from birth to six weeks with Type 1 SMA supported the marketing authorization extension, the company stated.
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