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Roche says four-year data confirms Evrysdi safety, efficacy for kids with SMA

Roche announced new long-term data for Evrysdi from the open-label extension of the pivotal FIREFISH study, “reinforcing its sustained efficacy and safety profile” in children with Type 1 spinal muscular atrophy, or SMA. FIREFISH is a two-part study in babies aged 1-7 months at the time of enrolment. After four years of treatment with Evrysdi, many of the babies, now young children, continued to improve their ability to sit, stand and walk without support. All the Evrysdi-treated children who were alive at the time of the primary analysis were still alive at month 48. Additionally, the majority of infants maintained their ability to feed by mouth and swallow up to month 48, Roche stated.

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