Mesoblast Ltd's approval application for its mesenchymal precursor cell, or MPC, therapy has been expedited as the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to the product.
The MPC therapy aims to treat heart failure patients with left ventricular systolic dysfunction and left ventricular assist devices.
The designation also allows for priority review of the therapy.
The U.S. FDA granted the designation based on the preliminary results of a placebo-controlled trial. The study reported improved heart function and improved survival rates in patients with heart implants along with a delay in internal bleeding caused by the same.
Mesoblast is conducting a phase 2b trial for the product. The company expects to have results from the trials by the first quarter of 2018.