Concert Pharmaceuticals Maintains Deuruxolitinib Breakthrough Therapy Designation from FDA for the Treatment of Alopecia Areata
Retrieved on:
Wednesday, February 15, 2023
Health, FDA, Other Health, Research, Science, Pharmaceutical, Biotechnology, Janus, Food, Judgement, Medication, Hair, Breakthrough, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough therapy, Maintenance, Patient, JAK, Alopecia areata, Pharmaceutical industry
Concert Pharmaceuticals, Inc. today announced that, after a recent review of deuruxolitinib clinical data by the U.S. Food and Drug Administration (FDA), the FDA determined that deuruxolitinib will maintain its Breakthrough Therapy designation.
Key Points:
- Concert Pharmaceuticals, Inc. today announced that, after a recent review of deuruxolitinib clinical data by the U.S. Food and Drug Administration (FDA), the FDA determined that deuruxolitinib will maintain its Breakthrough Therapy designation.
- 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.
- The FDA has now informed Concert that, after reviewing these data, the Breakthrough Therapy designation criteria continue to be met at this time.
- The FDA originally granted Breakthrough Therapy designation to deuruxolitinib for the treatment of adult patients with moderate to severe alopecia areata in 2020, which was supported by positive data from a Phase 2 clinical trial.