Amicus Therapeutics Says FDA Defers Filing For AT-GAA

(RTTNews) - Amicus Therapeutics (FOLD) Friday announced that the U.S. Food and Drug Administration has deferred action on the Biologics License Application for cipaglucosidase alfa, the biologic component of AT-GAA.

Due to restrictions on travel related to COVID-19, the FDA was unable to conduct the required inspection of the WuXi Biologics manufacturing site in China during the review cycle. As a result, the FDA is deferring action on the application until the manufacturing site inspection is complete.

The company continues to expect the FDA to approve the two components of AT-GAA, including the BLA and New Drug Application for miglustat, together.

"We are now one step away from the necessary approvals for AT-GAA in the U.S. We continue to believe this is a question of 'when' not 'if' AT-GAA will be approved and we will continue to work with great urgency to support the FDA's completion of the final plant inspection necessary for approval so that this important new treatment option is made available for people living with Pompe disease in the United States," said Bradley Campbell, President and Chief Executive Officer at Amicus Therapeutics, Inc. "We are also very pleased with the progress of the regulatory review in the EU and look forward to a Committee for Medicinal Products for Human Use ("CHMP") opinion by the end of the year. We remain committed to bringing AT-GAA to as many people living with Pompe disease around the world as quickly as possible."