Axogen Inc. Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration (FDA) for Avance Nerve Graft

ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft on May 15, 2024.

“Today’s milestone represents a significant step in our regulatory transition of Avance Nerve Graft to a biologic,” said Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “I am grateful to our Axogen team and their diligence as we work towards completing the rolling BLA submission process.”

The initial submission to the U.S. FDA includes the complete non-clinical data package for the BLA. Consistent with the agreed schedule, we plan to provide the remaining Clinical and Chemistry, Manufacturing and Controls (CMC) components in the coming months. The rolling submission process allows for the submission of pre-agreed components of the BLA to be submitted as they are completed, which can streamline the regulatory review process.

Avance Nerve Graft was granted a Regenerative Medicine Advanced Therapy (RMAT) designation. The RMAT designation, under the 21st Century Cures Act, aims to streamline the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions. A regenerative medicine therapy is eligible for the designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides a number of benefits including FDA guidance on efficient drug development and potential priority review of the BLA. Axogen will request priority review status for this BLA which, if granted, could reduce the standard review timeline from 10 months to the priority timeline of 6 months.

Approximately 45 to 60 days after the final components are submitted, FDA will provide a notification of formal acceptance and the review timeline. We anticipate the BLA filing to be completed in the third quarter of 2024 and we believe the procedural timelines for review combined with the rolling submission process will allow for approval around mid-2025.