Mesoblast has provided feedback received from the US Food & Drug Administration (FDA) on potential filing of a Biologics Licence Application (BLA) for its allogeneic cell therapy product rexlemestrocel-L in patients with Chronic discogenic Low Back Pain (CLBP). This follows FDA’s Type B meeting review of data from Mesoblast's first randomised controlled phase-III trial (MSB-DR003) on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration.

The company is seeking FDA approval for rexlemestrocel-L based on reduction in CLBP through 12 months. Comparing outcomes between rexlemestrocel-L and placebo from MSB-DR003 trial, FDA acknowledged that the effects on pain intensity appear to favour the active arm.

The FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated that the robust results on opioid reduction from at least one adequate and well-controlled trial could be included in the clinical studies section of product labeling.

A second randomised controlled phase-III trial, MSB-DR004, is actively recruiting across 40 sites in the US, is over 50 per cent enrolled, and is expected to complete the 300-patient enrollment target in the coming three months. CLBP is a major contributory factor to the US opioid crisis, and rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation from FDA for treatment of CLBP.

Silviu Itescu, Chief Executive, Mesoblast, said, "Rexlemestrocel-L could offer a powerful solution for management of chronic inflammatory back pain with the added potential to contribute to the administration's goals of opioid reduction or cessation."