Galera announces FDA acceptance, priority review of Avasopasem NDA

Galera Therapeutics announced that the U.S. Food and Drug Administration has accepted for filing and granted priority review to the New Drug Application for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients. With the 6-month priority review designation, the Prescription Drug User Fee Act target date assigned by the FDA for this NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application. The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of SOM induced by RT.