05:13 AM EDT, 03/11/2024 (MT Newswires) -- Mesoblast (MESO) said Sunday the US Food and Drug Administration supports an accelerated approval for its rexlemestrocel-L cell therapy in end-stage heart failure patients with a left ventricular assist device.
The regulator provided the feedback to the company in a February meeting. The product is being designed for patients with ischemic heart failure with reduced ejection fraction.
The company intends to request a pre-biological license application meeting with the FDA to discuss potential accelerated approvals for the therapy.