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. 
  • 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.
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