Lilly : CHMP Issues Positive Opinion For Olumiant For Severe Alopecia Areata Treatment

(RTTNews) - The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion for Olumiant (baricitinib) for the treatment of adults with severe alopecia areata (AA), Eli Lilly and Co. (LLY) and Incyte (INCY) said in a statement on Friday.

The European Commission's decision is expected in the next one to two months.

The positive opinion was based on Lilly's Phase 3 BRAVE-AA1 and BRAVE-AA2 trials evaluating the efficacy and safety of OLUMIANT in 1,200 patients with severe AA, the largest Phase 3 clinical trial program with completed primary endpoints.

In February 2022, the U.S. Food and Drug Administration granted priority review for OLUMIANT in adults with severe AA. Lilly expects additional regulatory decisions in the U.S. and Japan in 2022.