9 July 2018 - Aclaris Therapeutics announced today that the U.S. FDA has granted fast track designation to Aclaris’ investigational topical Janus kinase 1/3 inhibitor (ATI-502) for the treatment of alopecia areata, including patchy alopecia areata and the more severe variants of the disease, alopecia totalis and universalis.

The FDA’s fast track designation is intended to facilitate the development of new therapies for serious conditions and with the potential to address an unmet medical need. A company with an investigational medicine receiving Fast Track designation may be eligible for more frequent communications with the FDA and may receive an expedited review of the new drug application.

“This fast track designation represents a positive step for the development of ATI-502. This designation recognises the unmet need that exists for patients living with this often-devastating autoimmune disease and the impact of sudden or unpredictable hair loss,” said Christopher Powala, Chief Regulatory & Development Officer of Aclaris. “We look forward to working closely with the FDA throughout our development program with the hope of ultimately bringing this important treatment option to patients.”

Read Aclaris Therapeutics press release