On Sunday, Mesoblast Limited (NASDAQ:MESO) provided feedback received from the U.S. Food & Drug Administration (FDA) on potential filing of a Biologics License Application (BLA) for its allogeneic cell therapy product rexlemestrocel-L for chronic discogenic low back pain (CLBP).
The update follows FDA’s Type B meeting review of data from Mesoblast’s first randomized controlled Phase 3 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.
Mesoblast is seeking FDA approval for rexlemestrocel-L based on the reduction in CLBP through 12 months.
How Rexlemestrocel-L Could Help With Pain Management
Comparing outcomes between rexlemestrocel-L and placebo from the MSB-DR003 trial, the FDA acknowledged that the effects on pain intensity appear to favor the active arm.
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 randomized controlled Phase 3 trial, MSB-DR004, is recruiting participants and is over 50% enrolled, and is expected to complete the 300-patient enrollment target in the coming three months.
Rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for CLBP.
Can Aid With FDA Goal Of Opioid Reduction
Mesoblast CEO Silviu Itescu 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.”
A particular focus is on the treatment of patients on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the U.S.
Significant pain reduction and opioid cessation were observed in Mesoblast’s first Phase 3 trial.
In Mesoblast’s first randomized controlled Phase 3 trial of 404 patients, 168 of whom were taking opioids at baseline, more than 3-fold higher numbers of patients treated with a single intra-discal injection of rexlemestrocel-L + HA were able to cease use of all opioids by 36 months compared with saline-treated controls (p=0.008).
Mesoblast is also seeking accelerated FDA approval for Revascor (rexlemestrocel-L) for ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.
MESO Price Action: Mesoblast shares were down 3.41% at $16.85 at the time of publication on Tuesday, according to Benzinga Pro data.
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