NEW YORK - Mesoblast (NASDAQ:MESO) Limited (NASDAQ:MESO; ASX:MSB), a developer of allogeneic cellular medicines for inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has expressed support for an accelerated approval pathway for its product candidate rexlemestrocel-L.
This endorsement follows a Type B meeting held on February 21, 2024, where Mesoblast presented results from a pivotal study of rexlemestrocel-L in patients with end-stage ischemic heart failure who have had a left ventricular assist device (LVAD) implanted.
The FDA's feedback, according to Mesoblast CEO Dr. Silviu Itescu, suggests that the study's findings could support an accelerated approval based on a reasonable likelihood of clinical benefit in mortality reduction for LVAD patients. Mesoblast plans to request a pre-Biologics License Application (BLA) meeting to discuss the data and expectations for an accelerated approval filing.
Rexlemestrocel-L is an allogeneic mesenchymal precursor cell (MPC) therapy intended to modulate the inflammatory response in ischemic heart disease. The study highlighted that patients treated with rexlemestrocel-L showed normalized levels of the inflammatory cytokine IL-6, improved ability to wean from LVAD support, and significantly reduced mortality compared to the control group.
In the U.S., over 100,000 patients progress to end-stage heart failure annually, and more than 2,500 LVADs are implanted each year, many as permanent therapy. Patients with ischemic heart failure have a lower chance of heart function recovery post-LVAD implantation and face higher mortality rates in the first couple of years.
Mesoblast's product candidate has previously received the Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the FDA for patients with end-stage heart failure implanted with an LVAD. The company's broader portfolio includes therapies for various severe inflammatory conditions, with a focus on leveraging its proprietary mesenchymal lineage cell therapy platform.
The information in this article is based on a press release statement from Mesoblast Limited.
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