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Updated: 20-Apr-21 06:51 ET

LLY: Eli Lilly and Incyte (INCY) announce results from second Phase 3 trial evaluating efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata; data are consistent with findings from the first Phase 3 clinical trial (189.64)

LLY and Incyte (INCY) announce results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata. The data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, top-lined earlier this year.
In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.
The most common treatment-emergent adverse events in BRAVE-AA1 and BRAVE-AA2 included upper respiratory tract infections, headache and acne. No deaths or venous thromboembolic events were reported in the trials. The safety profile of baricitinib in the two studies was consistent with its known safety profile in patients with rheumatoid arthritis and atopic dermatitis.
Based on these results, LLY plans to submit a supplemental New Drug Application to the FDA for baricitinib in AA in the second half of 2021, followed by submissions to other regulatory agencies around the world. In Q1 2020, baricitinib received Breakthrough Therapy designation from the FDA for the treatment of AA.