Organogenesis Plans Rolling BLA Submission for ReNu by End-2025 After FDA Meeting
Organogenesis secured FDA agreement to initiate a rolling BLA for ReNu with submission planned before December 2025 following two large Phase 3 RCTs and RMAT designation. The therapy targets a knee osteoarthritis market affecting over 31 million Americans, potentially addressing a major unmet need.
1. FDA Meeting Outcome
Organogenesis completed a Type-B meeting with the FDA, which confirmed the clinical development program for ReNu is appropriate for a rolling BLA and outlined expectations for submission before the end of December 2025.
2. ReNu Clinical Program
ReNu’s development includes two large Phase 3 randomized controlled trials involving over 1,300 patients and holds Regenerative Medicine Advanced Therapy designation, supporting its biologics license application.
3. Market Opportunity and Potential
Knee osteoarthritis affects an estimated 31.1 million Americans, projected to reach 34.4 million by 2027, with end-stage patients typically undergoing total knee replacement, underscoring a substantial market need for ReNu.