FDA accepts Organogenesis BLA for knee osteoarthritis treatment ReNu

Organogenesis Holdings Inc. (Nasdaq: ORGO) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for ReNu®, a cryopreserved amniotic suspension allograft intended to treat pain associated with symptomatic knee osteoarthritis.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.

ReNu consists of amniotic fluid cells and micronized amniotic membrane, containing cellular, growth factor, and extracellular matrix components. The product received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis in 2021 and has been studied in three randomized controlled trials involving more than 1,300 patients.

The FDA has conditionally accepted Amnuvx (azimplacel) as the proprietary name for the product, pending further FDA review and approval.

Patrick Bilbo, Chief Operating Officer of Organogenesis, said the company looks forward to working with the FDA as it completes its review.

Knee osteoarthritis is a degenerative joint disease estimated to affect nearly 31 million Americans, according to the press release.

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