United states food & drug administration (fda) supports accelerated approval pathway for rexlemestrocel-l in end-stage heart failure patients with a left ventricular assist device (lvad)

New york, march 10, 2024 (globe newswire) -- mesoblast limited (nasdaq:meso; asx:msb), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that u.s. fda supports an accelerated approval pathway for rexlemestrocel-l, mesoblast's allogeneic mesenchymal precursor cell (mpc) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (hfref) and a left ventricular assist device (lvad). fda provided this feedback in formal minutes to the company following the type b meeting held with fda on february 21, 2024 for rexlemestrocel-l (revascor®) under the existing regenerative medicine advanced therapy (rmat) designation.
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