Mesoblast Limited received feedback from the FDA on potentially filing a Biologics License Application for rexlemestrocel-L, a cell therapy for chronic discogenic low back pain. FDA noted positive outcomes in pain reduction and opioid use in the Phase 3 trial. A second trial is underway to enroll 300 patients. Rexlemestrocel-L aims to reduce chronic low back pain through a 12-month study. The therapy has shown promise in reducing pain intensity and opioid usage, contributing to the fight against the opioid crisis in the U.S. Mesoblast is a leader in developing cellular medicines for inflammatory conditions.

Read more at GlobeNewswire: FDA Acknowledges Effects on Pain Intensity Favor