FDA Approves Acellular Nerve Allograft for Sensory Nerve Repair

The FDA has approved Avance® (acellular nerve allograft-arwx) for treating sensory nerve discontinuity. Derived from cadaveric nerve tissue, Avance bridges gaps in injured peripheral nerves to restore function. Its processing removes cellular components to minimize rejection risk.

Avance is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities.

Avance was studied in patients with sensory nerve discontinuities and additional investigations of mixed and motor nerve discontinuities.

“Avance can bridge gaps in damaged nerves and support nerve function restoration,” said Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Current treatment options, such as autografts, have limitations, so this approval addresses a significant unmet medical need for patients with peripheral nerve injuries.”

Unlike some current treatments that require surgeons to remove healthy nerve tissue from another part of the patient's body (creating a second surgical site), Avance is made using nerve tissue from deceased donors (cadavers) that has been specially processed to remove cells while preserving the natural structure that helps nerves regrow.

“Avance eliminates the need for patients to undergo additional surgery to harvest their own nerve tissue for repair,” said Vijay Kumar, M.D., Acting Director of the Office of Therapeutic Products, CBER. “The agency has exercised regulatory flexibility in expanding the indication for Avance to motor and mixed nerve injuries, and sensory nerves with gaps exceeding 25 mm, through the Accelerated Approval pathway based on a surrogate endpoint that is reasonably likely to predict clinical benefit. The accelerated approval is subject to the requirement that the applicant conduct and submit the results of confirmatory clinical trials.”

The study of Avance’s efficacy compared implantation of Avance to collagen nerve cuffs. The study met its primary endpoint for the return of sensory function, showing Avance’s statistical non-inferiority to comparator nerve cuff.

The most common adverse reactions reported in clinical trials were procedural pain and increased sensitivity to sensory stimuli, such as touch, temperature, and pain (hyperesthesia). Patients should be monitored for procedural complications including pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding and neuroma formation. Avance is made from human cadaveric tissue so it may carry a risk of transmitting infectious agents. No cases of transmission of viral diseases have ever been identified for Avance. All infections thought to be transmitted by Avance should be reported to the manufacturer.

FDA approval for Avance was granted to Axogen Corporation.