Mesoblast updates on pathway to US approval

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Mesoblast (ASX:MSB) has provided an update on the strategy for bringing rexlemestrocel-L to patients in the US with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies.

The company said the excessive use of opioids in this patient population continues to be a major focus for US healthcare policymakers, regulatory authorities, patients and physicians, with more than 50 per cent of US opioid prescriptions being for the treatment of CLBP.

Mesoblast said it has filed a request and expects to hold a Type C meeting with the FDA during the current quarter to discuss the pathway to US regulatory approval for rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic inflammatory back pain due to degenerative disc disease.

“We look forward to discussing with the FDA the most efficient path forward given the durable pain reduction for at least two years and the opioid-sparing activity from a single administration of rexlemestrocel-L that was observed in the recent Phase 3 trial” said Dr Fred Grossman, chief medical officer of Mesoblast.

Mesoblast said it plans to leverage the results from a planned US trial to support potential product approvals in both US and EU by including 20 per cent EU patients in order to provide regulatory harmonization, cost efficiencies and streamlined timelines, without initiating an EU trial.

"In line with this strategy, Mesoblast and its partner in Europe and Latin America, Grünenthal, have amended their collaboration agreement, with Mesoblast being eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive of US$17.5 million already received if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved," said the company.