Australian drug developer Mesoblast Ltd said the U.S. Food and Drug Administration would fast-track the review of its cell therapy treatment for heart failure patients under a new designation rolled out last December.
Mesoblast’s mesenchymal precursor cell (MPC) therapy, aiming to mitigate advanced heart failure, received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, the company said.
The designation is based on the preliminary clinical trial data, the company said, adding that a mid-stage trial was being conducted in 159 patients with heart failure and left ventricular assist devices (LVADs).
A single dose consists of 150 million highly purified stem cells that are delivered directly to the heart’s left ventricle by injection or catheter, reducing inflammation and increasing blood flow to spur blood vessel formation that helps repair the heart muscle.
Mesoblast is seen as among the farthest along in the stem cell industry at a time when Wall Street investors have focused on potentially big payoffs from immune-system based cancer therapies and rare diseases.
(Reporting by Mekhla Raina in Bengaluru; Editing by Amrutha Gayathri)