CHMP Backs Approval of Lilly/Incyte's Olumiant For Patchy Hair Loss

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eli Lilly And Co LLY and Incyte Corporation's INCY Olumiant (baricitinib) for severe alopecia areata (AA).
If approved, Olumiant would be the first centrally-authorized oral treatment and first JAK inhibitor for severe AA in the European Union.
The positive opinion was based on Lilly's Phase 3 BRAVE-AA1 and BRAVE-AA2 trials.
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Across both studies, 1 out of 3 patients treated with Olumiant 4-mg achieved 80% or more scalp hair coverage, compared to 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively.
Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen at 36 weeks.
In February, the FDA granted priority review for Olumiant. Lilly expects additional regulatory decisions in the U.S. and Japan in 2022.
Price Action: INCY shares are trading at $73.74, and LLY shares are up 3.51% at $296.32 during the market session on the last check Friday.