Eli Lilly Says 2nd Late-stage Study Of Baricitinib Achieved Main Goal- Quick Facts

Eli Lilly and Company (LLY) and Incyte (INCY) today reported the second late-stage study of baricitinib met primary endpoint of improved hair regrowth in patients with alopecia areata (AA).

AA is an autoimmune disease that causes patchy hair loss.

The data from the second Phase 3 study of baricitinib in AA, dubbed BRAVE-AA1, are consistent with the first Phase 3 study, dubbed BRAVE-AA2, top-lined earlier this year.

In both studies, a statistically significant proportion of patients treated with baricitinib 2-mg and 4-mg achieved the primary endpoint of hair regrowth at Week 36 compared to patients treated with placebo, the companies said.

"There is a pressing need for approved treatment options for people suffering from alopecia areata as existing topicals and steroids do not provide meaningful improvement for many patients," said Maryanne Senna, dermatologist and assistant professor of dermatology at Harvard Medical School and clinical trial investigator of BRAVE-AA1.

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

Baricitinib is approved and commercially available as Olumiant in the U.S. and more than 70 countries for the treatment of rheumatoid arthritis and in Europe and Japan for the treatment of atopic dermatitis.

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