Pfizer Inc. said the U.S. Food and Drug Administration granted the breakthrough therapy designation to its hair loss medicine PF-06651600.
The New York-based pharmaceutical giant's PF-06651600 is intended to treat patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face or body.
There are no FDA approved treatments for alopecia areata, which impacts millions of people worldwide.
Under the FDA's breakthrough therapy designation, the regulator expedites the development and review of drugs that demonstrate substantial improvement over existing therapies to treat a serious or life-threatening disease or condition.
Pfizer said the U.S. regulator granted the designation based on data from a phase 2 trial, results from which will be released at the 27th European Academy of Dermatology and Venerology Congress in Paris later this month.