PTC Therapeutics Says Evrysdi Approved in Brazil, Japan NDA Filed
October 21 2020 - 9:36AM
Dow Jones News
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.
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