Chugai gains Japan approval for Evrysdi as first tablet for SMA

31 March 2025

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for Evrysdi Tablets 5mg, a new formulation of the spinal muscular atrophy (SMA) treatment risdiplam.

Chugai said that Evrysdi is currently the only orally administered treatment for SMA. While the currently available dry syrup can be taken regardless of age and weight, the newly approved tablet formulation provides an additional option for people with SMA who are 2 years of age or older and weigh 20 kg or more.

Evrysdi generated sales of 15.9 billion yen ($106 million) in full year 2024, up 9.7% on 2023, for Chugai, which is majority-owned by Swiss pharma giant Roche (ROG: SIX), which leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. The 5mg tablet formulation was approved by the US Food and Drug Administration (FDA) in February this year.

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