Mesoblast Limited, known commercially as MESO or MSB.AX, announced that the U.S. Food and Drug Administration (FDA) is supporting a fast track approval process for their allogeneic mesenchymal precursor cell product, dubbed rexlemestrocel-L. This product is designed for individuals with advanced ischemic heart failure with a decreased ejection fraction (HFrEF) and who have a left ventricular assist device (LVAD).
The FDA shared their opinions in formal minutes after a Type B meeting with Mesoblast on February 21, 2024. During this meeting, the FDA discussed its existing Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L, also known by its commercial name Revascor.
The FDA's response to Mesoblast indicated that the efficacy data provided by the company could potentially show that rexlemestrocel-L has a reasonable chance of providing a genuine clinical benefit for LVAD patients, thus meeting the criteria needed for expedited approval.
Mesoblast is planning to arrange a preliminary Biologics License Application (pre-BLA) meeting with the FDA where they intend to discuss the presentation of data, schedules, and the FDA's expectations for an accelerated approval application for patients with advanced ischemic HFrEF and an LVAD.
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