Avasopasem manganese FDA Approval Status
Last updated by Judith Stewart, BPharm on Dec 20, 2022.
FDA Approved: No
Generic name: avasopasem manganese
Company: Galera Therapeutics, Inc.
Treatment for: Mucositis
Avasopasem manganese is a selective small molecule dismutase mimetic in development for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.
- Severe oral mucositis is severe mouth inflammation defined by the inability to eat solid food or drink liquids.
- Avasopasem manganese works as a radioprotector to reduce side effects from radiation therapy.
- Avasopasem has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration for the reduction of the incidence and severity of radiation induced oral mucositis in head and neck cancer.
- On August 9, 2023, Galera Therapeutics, Inc. announced that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial were not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. FDA stated that results from an additional clinical trial would be required for resubmission.
Development timeline for avasopasem manganese
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
