FDA Acknowledges Effects on Pain Intensity Favor Rexlemestrocel-L, Confirms 12-Month Reduction in Back Pain Supports Product Efficacy

Core Insights - Mesoblast Limited is seeking FDA approval for its allogeneic cell therapy product rexlemestrocel-L aimed at treating chronic discogenic low back pain (CLBP) and potentially reducing opioid use [1][2][3] Group 1: FDA Feedback and Clinical Trials - The FDA has provided feedback indicating that a clinically meaningful reduction in pain intensity at 12 months can support the efficacy of rexlemestrocel-L [2] - The first Phase 3 trial (MSB-DR003) demonstrated significant pain reduction and opioid cessation, with over three times more patients able to stop using opioids compared to controls [7] - A second Phase 3 trial (MSB-DR004) is currently recruiting and is expected to complete enrollment of 300 patients within three months [3][5] Group 2: Opioid Crisis and Treatment Implications - CLBP is a major contributor to the U.S. opioid crisis, accounting for approximately 50% of prescription opioid usage [6][10] - The FDA has designated rexlemestrocel-L as a Regenerative Medicine Advanced Therapy (RMAT), which allows for expedited review processes [8] - Mesoblast's CEO highlighted the potential of rexlemestrocel-L to help manage chronic inflammatory back pain while contributing to opioid reduction goals [4] Group 3: Market Context and Company Overview - Chronic low back pain affects over 7 million people in the U.S. and is a leading cause of disability [9] - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, with a strong intellectual property portfolio [11][14] - The company is also developing additional therapies for other inflammatory diseases and has established commercial partnerships in various regions [13]