European Commission Clears Label Extension for Roche’s Evrysdi

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In a company press release, Roche revealed that the European Commission (EC) has approved the extension of Evrysdi for infants with a clinical diagnosis of spinal muscular atrophy (SMA) from birth to below two months of age. The approval comes amid positive data from the ongoing rainbowfish trial in pre-symptomatic babies from birth to six weeks with type 1 SMA.

“With this label extension, we can treat babies soon after birth with Evrysdi, allowing them the greatest chance to achieve the milestones of sitting, standing, and walking, similar to healthy children,” said Levi Garraway, MD, PhD., chief medical officer, head of global product development, Roche, in the company release.

Reference: European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA). Roche. August 29, 2023. Accessed August 29, 2023. https://www.roche.com/media/releases/med-cor-2023-08-29