Axogen has received FDA approval for its Biologics License Application for Avance® (acellular nerve allograft-arwx), formally recognizing the product under the biologics framework. This validates prior clinical evidence and supports broader clinical adoption, particularly as Avance targets challenging nerve repair settings.
Key indications for sensory nerve discontinuities greater than 25 mm and for mixed and motor nerve discontinuities were granted via the FDA’s Accelerated Approval pathway. That pathway relies on improvements in static two-point discrimination in sensory nerve gaps of 25 mm or less as an empirical surrogate for clinical benefit. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies, adding an execution and data-generation requirement.
The company expects licensed Avance to become commercially available in early Q2 2026, while remaining available under the current tissue framework in the meantime. This timing gives a clear transition from the legacy framework to the licensed biologic, and future disclosures around confirmatory study progress and results will be important in determining the durability of the accelerated approval indications.
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