Concert: FDA keeps ‘Breakthrough Therapy’ designation for deuruxolitinib

Concert Pharmaceuticals announced that, after a recent review of deuruxolitinib clinical data by the U.S. Food and Drug Administration , the FDA determined that deuruxolitinib will maintain its Breakthrough Therapy designation. Deuruxolitinib, an oral Janus kinase,JAK, inhibitor, is being developed for the treatment of adult patients with moderate to severe alopecia areata. In light of the FDA approval of a different JAK inhibitor as the first treatment for alopecia areata, the FDA previously notified Concert that it was reviewing the Breakthrough Therapy designation previously granted for deuruxolitinib. At the FDA’s request, Concert submitted additional clinical data and justification to support the continued eligibility of deuruxolitinib for the designation. The FDA has now informed Concert that, after reviewing these data, the Breakthrough Therapy designation criteria continue to be met at this time.