Longeveron Gets FDA Fast-Track Designation for Lomecel-B in Heart Defect

 Longeveron Inc. on Wednesday said the U.S. Food and Drug Administration granted fast-track designation to Lomecel-B, the company's lead program, for the treatment of hypoplastic left heart syndrome in infants.

The Miami clinical-stage biotechnology company is currently studying Lomecel-B in a Phase 2a trial for the rare and life-threatening congenital heart defect, which affects about 1,000 infants a year.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Longeveron previously received the FDA's orphan-drug and rare-pediatric-disease designations for Lomecel-B in hypoplastic left heart syndrome.

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