FDA Grants Fast-Track Designation to Aclaris Therapeutics’ Investigational JAK Inhibitor
Aclaris Therapeutics, Inc. recently announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Aclaris’ investigational topical Janus Kinase (JAK) 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 recognizes 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.”
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. AA can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the FDA for the treatment of AA.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology. Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For more information, visit www.aclaristx.com.
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