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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