Evrysdi cleared for spinal muscular atrophy in Japan

24 June 2021
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Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval for Evrysdi (risdiplam) Dry Syrup 60mg for the treatment of spinal muscular atrophy (SMA).

Evrysdi had been granted an orphan drug designation in March 2019, and Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss pharma giant Roche (ROG: SIX), filed a regulatory application in October 2020.

Driven by its novel and convenient mode of administration, analysts have forecast that Evrysdi could generate up to $2 billion at peak, competing with existing treatments such as Biogen’s (Nasdaq: BIIB) Spinraza (nusinersen) and Novartis’ (NOVN: V) Zolgensma (onasemnogene abeparvovec).

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