Mesoblast has received positive feedback from the US Food and Drug Administration (FDA) regarding a potential biologics license application for its allogeneic cell therapy, rexlemestrocel-L, aimed at treating chronic discogenic low back pain. This feedback follows a Type B meeting with the FDA, where data from Mesoblast’s Phase 3 trial (MSB-DR003) was reviewed. The trial assessed pain reduction and opioid use over three years following a single administration of rexlemestrocel-L. Mesoblast is a regenerative medicine company focused on developing innovative cellular medicines to address unmet medical needs. The company’s proprietary cell therapy technology platform has applications in inflammatory conditions, cardiovascular diseases, and other areas.
The FDA noted that the data indicated “effects on pain intensity appear to favour the active arm,” suggesting a positive trend for rexlemestrocel-L. The regulator confirmed that a clinically meaningful reduction in pain at 12 months compared to placebo could support the efficacy of the product. Furthermore, the FDA indicated that data related to opioid reduction could be included in the product’s labelling, potentially enhancing its market appeal and utility.
Mesoblast chief executive Silviu Itescu commented on the feedback, stating that “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.” This reflects the company’s optimism about the potential of rexlemestrocel-L to address a significant medical need while aligning with public health priorities. In early trading on Monday, Mesoblast shares experienced a slight dip of 0.4 per cent.
