SMA drug Evrysdi approved in Brazil; filed in Japan

21 October 2020

Evrysdi (risdiplam) has been approved in Brazil by the National Health Surveillance Agency (ANVISA) for the treatment of spinal muscular atrophy (SMA), the drug’s developer, PTC Therapeutics (Nasdaq: PTCT), announced today.

The approval was obtained within seven months of licensee Roche's (ROG: SIX) initial submission and marks the second country to approve Evrysdi.

Additionally, PTC announced the filing of a New Drug Application (NDA) for Evrysdi for the treatment of SMA with the Japanese Ministry of Health, Labor and Welfare (MHLW). The filing in Japan by Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche, and triggers a $7.5 million milestone payment to PTC from Roche.

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