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

Core Insights - Axogen, Inc. has initiated the rolling submission process for a Biologics License Application (BLA) for Avance Nerve Graft, marking a significant regulatory milestone [1] - The initial submission includes a complete non-clinical data package, with remaining clinical and Chemistry, Manufacturing and Controls (CMC) components to be submitted in the coming months [1][3] - The Avance Nerve Graft has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may allow for priority review and a reduced review timeline from 10 months to 6 months [2] Regulatory Process - The rolling submission process allows for pre-agreed components of the BLA to be submitted as they are completed, potentially streamlining the regulatory review [1] - Following the final component submission, the FDA will notify Axogen of formal acceptance and the review timeline approximately 45 to 60 days later [3] - The BLA filing is anticipated to be completed in the third quarter of 2024, with potential approval expected around mid-2025 [3] Company Overview - Axogen is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring nerve function and quality of life for patients [4] - The company offers a comprehensive portfolio of products for various applications, including traumatic injuries and surgical treatments, addressing both scheduled and emergent procedures [5] - Key products include Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, among others, which are designed to facilitate nerve repair and protection [6][7]