Axogen, Inc, a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for AVANCE (acellular nerve allograft-arwx).

Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

The indications for sensory nerve discontinuities >25mm and for mixed and motor nerve discontinuities were approved under the FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps ≤25mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies.

“All stakeholders in Axogen’s mission to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care should take great pride in today’s approval,” said Michael Dale, Axogen’s Chief Executive Officer. “This approval represents a meaningful shift from our historical classification as a human tissue product and brings the product in line with the FDA’s classification of Avance as a biologic. This milestone clarifies and strengthens our regulatory footing and confirms approval for use of Avance as an acceptable therapeutic option for treating peripheral nerve discontinuities in all of Axogen’s present nerve repair use cases. The approved BLA and successful transition of Avance to a biologic regulatory framework should give all stakeholders the assurance that Avance has been rigorously evaluated and determined to be safe, pure, and potent for its intended use, and that its benefits outweigh its known or potential risks. We want to thank the FDA and the surgical community for the tremendous work and collaboration over more than a decade to make this therapy available to patients.”