- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eli Lilly And Co (NYSE:LLY) and Incyte Corporation's (NASDAQ: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.
- Read Next: Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19.
- 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.
