Lilly, Incyte Present Detailed Results From OLUMIANT BRAVE-AA1, BRAVE-AA2 Trials In Alopecia Areata

(RTTNews) - Eli Lilly and Co. (LLY) and Incyte (INCY) announced Thursday detailed results from two pivotal Phase 3 trials of OLUMIANT (baricitinib) in treating Alopecia Areata or AA.

The results from BRAVE-AA1 and BRAVE-AA2 found that once-daily OLUMIANT (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe AA as defined by =50% scalp hair loss at baseline.

AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress.

The company noted that significant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking OLUMIANT 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year.

In both studies, a greater proportion of patients taking OLUMIANT 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies.

These results, along with safety data in adult patients with moderate to severe atopic dermatitis or AD, are being presented virtually at the 30th European Academy of Dermatology and Venerology (EADV) Congress, taking place from Sept. 29-Oct. 2, 2021.

OLUMIANT has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of AA.

Lilly plans to submit a supplemental New Drug Application or sNDA to the FDA for OLUMIANT in AA in the second half of 2021.

OLUMIANT was developed by Incyte and licensed to Lilly.