By Michael Dabaie

 

PTC Therapeutics Inc. said Wednesday Evrysdi was approved in Brazil by the National Health Surveillance Agency for the treatment of spinal muscular atrophy.

PTC said the approval was obtained within seven months of Roche's initial submission and marks the second country to approve Evrysdi. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Additionally, PTC said a new drug application was filed for Evrysdi for the treatment of SMA with the Japanese Ministry of Health, Labor and Welfare. The filing in Japan by Chugai Pharmaceutical Co. Ltd., part of the Roche group, triggers a $7.5 million milestone payment to PTC from Roche.

Spinal muscular atrophy is a severe, progressive neuromuscular disease that can be fatal.

The U.S. Food and Drug Administration approved Evrysdi in August. Evrysdi is marketed in the U.S. by Roche's Genentech.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

October 21, 2020 09:21 ET (13:21 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
PTC Therapeutics (NASDAQ:PTCT)
Historical Stock Chart
From Nov 2020 to Dec 2020 Click Here for more PTC Therapeutics Charts.
PTC Therapeutics (NASDAQ:PTCT)
Historical Stock Chart
From Dec 2019 to Dec 2020 Click Here for more PTC Therapeutics Charts.