Eli Lilly and Incyte Corporation announced that the US FDA has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA).
Currently, there is no FDA-approved treatment for AA, an autoimmune 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 BRAVE-AA1 phase 2/3 study, which evaluated treatment with baricitinib versus placebo in adult patients with AA.
In the phase 2 portion of the BRAVE-AA1 study up to week 36, there were no new safety signals with no serious adverse events reported.
Based on the interim results of the phase 2 part of the study, the phase 3 portion of BRAVE-AA1 and an additional phase 3 double-blind study (BRAVE-AA2), are currently assessing the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.
Baricitinib is a once-daily, oral JAK inhibitor approved in more than 65 countries for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies.