FDA grants orphan drug designation to cell therapy for Buerger’s disease
The U.S. Food and Drug Administration granted orphan drug designation to CLBS12 (Caladrius Biosciences, Inc), a CD34+ cell therapy, for the treatment of Buerger’s disease, according to a press release.
Buerger’s disease is a rare disorder characterized by narrowing of the veins and arteries of the extremities.
“We are very pleased that the FDA has granted orphan drug designation to CLBS12 in Buerger’s disease. Without a currently approved or effective treatment for this condition in the U.S., a significant unmet need remains for therapies that slow, stop or, ideally, reverse this debilitating disease,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius in a press release. “The Company’s ongoing open-label, registration-eligible study of HONEDRA (CLBS12) as a treatment for CLI and Buerger’s Disease in Japan has shown strong results to date with approximately 60% of subjects in the completed Buerger’s Disease cohort reaching a positive ‘CLI-free’ endpoint despite the natural history of continuous disease progression leading to amputation. With this designation we can now engage FDA in discussions to define the most efficient and rapid development pathway to registration in the U.S. Achieving orphan designation for CLBS12 takes us one step closer to realizing our goal of fulfilling the unmet medical need for Buerger’s Disease patients around the world.”
Read the full press release here.