USFDAJul 6, 2026, 04:06 PM
Organogenesis FDA Accepts ReNu BLA for Knee OA; PDUFA April 24, 2027
AI Summary
Organogenesis Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for ReNu®. ReNu® is a cryopreserved, amniotic suspension allograft designed to treat pain in symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027, marking a significant step towards potentially bringing a new non-surgical biologic therapy to market for millions of Americans suffering from knee OA.
Key Highlights
- FDA accepted Organogenesis's Biologics License Application (BLA) for ReNu® for review.
- ReNu® is developed for the treatment of pain in symptomatic knee osteoarthritis (OA).
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.
- ReNu® is a cryopreserved, amniotic suspension allograft containing cellular, growth factor, and extracellular matrix components.
- Knee OA affects an estimated 31 million Americans, projected to grow to over 34 million by 2027.
- ReNu® received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Knee OA in 2021.
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