8 July 2020 - Designation based on Phase 2 data demonstrating significant hair regrowth in patients with alopecia areata.
Concert Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata.
There are currently no drugs approved by the FDA for the treatment of alopecia areata, an auto-immune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss.