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Genentech: FDA Approves Evrysdi For Babies Under Two Months Of Age With Spinal Muscular Atrophy

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Genentech, a member of the Roche Group (RHHBY), announced the FDA has approved a label extension for Evrysdi to include babies under two months old with spinal muscular atrophy. Evrysdi is now approved to treat spinal muscular atrophy in children and adults of all ages.

The company noted that, as part of the label extension, the Evrysdi prescribing information has been updated to include recent two-year pooled data from parts 1 and 2 of the FIREFISH study, which showed long-term efficacy and safety in symptomatic infants with Type 1 SMA.

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