Amicus eyes Pompe approval; Atea ends Dengue work; 2seventy, Travere line up offerings
Amicus Therapeutics began March with word that the FDA has scheduled a pre-approval inspection of its potential treatment for Pompe disease. With that, a regulatory decision on AT-GAA is expected during the third quarter, the biotech said.
Amicus said last October the FDA wasn’t able to do the required inspection of its manufacturing partner, WuXi Biologics in China, during the review timeframe because of “restrictions on travel related” to the pandemic. AT-GAA consists of biologic cipaglucosidase alfa and miglustat, a stabilizer of the biologic. The approval request includes both a BLA and NDA.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.