Drug Profile

Human nerve allograft - AxoGen

Alternative Names: Avance Nerve Graft; Processed Human Nerve Tissue Scaffold - AxoGen; Processed Nerve Allograft - AxoGen

Latest Information Update: 01 Sep 2025

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At a glance

Originator Axogen
Class Collagens; Tissue extracts
Mechanism of Action Tissue replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Preregistration Peripheral nerve injuries

Most Recent Events

25 Aug 2025 US FDA assigns PDUFA action date of (05/12/2025) for Human nerve allograft for Peripheral nerve injuries
21 Nov 2024 US FDA accepts BLA for Avance® Nerve Graft for Peripheral nerve injuries for review
06 Sep 2024 Axogen completes the rolling submission process for Biologics license application (BLA) to the US FDA for Human nerve allograft

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