Organogenesis Holdings Inc. (NASDAQ: ORGO) has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for ReNu®, a cryopreserved, amniotic suspension allograft aimed at treating pain associated with symptomatic knee osteoarthritis (OA).
The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for April 24, 2027.
Knee osteoarthritis is a prevalent degenerative joint disease affecting nearly 31 million Americans and is a leading cause of disability and reduced quality of life, characterized by pain and functional limitations.
Patrick Bilbo, Chief Operating Officer, stated, We are pleased to reach this important milestone and look forward to working with the FDA as they complete their review. We are now one step closer to our goal of bringing the first non-surgical biologic therapy to the millions of Americans whose lives are impacted by knee OA pain.”
The FDA has also conditionally accepted the proprietary name Amnuvx (azimplacel) for the product, pending further review and approval.
