← Back to feed FDA accepts Organogenesis's ReNu BLA for symptomatic knee osteoarthritis Sponsor Organogenesis Holdings
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Drug ReNu · cryopreserved amniotic suspension allograft
Indication Management of pain in symptomatic knee osteoarthritis More on Organogenesis Holdings ↗ Google News FDA accepted Organogenesis Holdings's Biologics License Application for ReNu — a cryopreserved amniotic suspension allograft — for the management of pain in symptomatic knee osteoarthritis. The PDUFA target action date is set for April 24, 2027. If approved, ReNu would be the first FDA-approved non-surgical biologic therapy for knee OA, an indication with ~31 million U.S. patients and no regenerative-therapy incumbent.
Read original at globenewswire.com ↗ Background Drug-class context · Wikipedia Osteoarthritis (OA) is a degenerative joint disease characterised by progressive cartilage loss, subchondral bone remodelling, osteophyte formation, and synovial inflammation. Knee OA is the most common musculoskeletal cause of disability in adults, estimated by Organogenesis to affect nearly 31 million Americans and projected to exceed 34 million by 2027. Current non-surgical management is stepwise and largely symptomatic — acetaminophen, oral and topical NSAIDs, intra-articular corticosteroid injections, and intra-articular hyaluronic acid — none of which are FDA-approved to modify disease progression. Total knee arthroplasty remains the definitive intervention for end-stage disease. No FDA-approved biologic or regenerative therapy currently exists specifically for the intra-articular treatment of knee OA pain. ReNu is a cryopreserved suspension of amniotic-derived cells and signalling molecules developed for intra-articular administration; the BLA is supported by three randomised controlled trials enrolling more than 1,300 patients. Organogenesis's rolling BLA submission opened December 2025 and completed April 2026; the FDA's July 6, 2026 acceptance sets a PDUFA target action date of April 24, 2027, consistent with Standard Review. Approval would make ReNu the first FDA-approved non-surgical biologic therapy for knee OA.
Source: Wikipedia · CC BY-SA
Topic osteoarthritis
