16 March 2020 - Recognition reinforces baricitinib's potential to be the first FDA approved medicine for individuals living with alopecia areata.
Eli Lilly and Incyte Corporation announced today that the U.S. FDA has granted breakthrough therapy designation to baricitinib for the treatment of alopecia areata (AA), an auto-immune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.
The FDA breakthrough therapy designation is based on the positive Phase 2 results of Lilly's adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib versus placebo in adult patients with AA.