FDA Accepts Organogenesis BLA for ReNu, Sets April 24, 2027 PDUFA Date
ORGO•The FDA has accepted Organogenesis’s Biologics License Application for ReNu®, setting a PDUFA action date of April 24, 2027. ReNu® is a cryopreserved amniotic suspension allograft studied in three RCTs with over 1,300 patients for symptomatic knee osteoarthritis.
1. Application Acceptance
The FDA completed its filing determination and formally accepted the BLA submission for ReNu®, advancing the application into the review phase for knee osteoarthritis treatment.
2. PDUFA Timeline
A Prescription Drug User Fee Act target action date of April 24, 2027 has been assigned, marking the deadline for the FDA’s approval decision on ReNu®.
3. Clinical Trial Data
ReNu® has undergone three randomized controlled trials involving more than 1,300 patients and received Regenerative Medicine Advanced Therapy designation in 2021, supporting its safety and efficacy profile.
4. Market Opportunity
Knee osteoarthritis affects an estimated 31 million Americans and is projected to grow to over 34 million by 2027, highlighting a substantial market for a non-surgical biologic therapy.
