FDA grants Fast Track designation to Concert Pharmaceuticals’ CTP-543 for the treatment of alopecia aerata.
Concert Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel, oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss.
Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and address unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged throughout the drug development and review process to help to ensure that questions are resolved quickly.
“Fast Track designation recognizes that alopecia areata is a serious disease in need of effective treatments,” said James Cassella, Ph.D., chief development officer of Concert Pharmaceuticals. “We look forward to collaborating with the FDA on the development of CTP-543. There are no FDA-approved treatments for alopecia areata and CTP-543 would represent a significant medical advance as a potential first-in-class treatment for moderate-to-severe disease.”
Concert is conducting a multi-center, double-blind, randomized, placebo-controlled Phase 2a trial to evaluate the safety and efficacy of CTP-543 in adults with moderate-to-severe alopecia areata. For additional information on the ongoing CTP-543 Phase 2a trial, see www.clinicaltrials.gov.
Filed Under: Drug Discovery