INCY - Lilly Incyte's Olumiant get EMA panel nod for hair loss disorder alopecia areata
A committee of the European Medicines Agency (EMA) recommended the approval of Eli Lilly (NYSE:LLY) and Incyte's (NASDAQ:INCY) Olumiant to treat adults with severe alopecia areata (AA). Olumiant is already approved in the EU to treat certain patients with rheumatoid arthritis, and atopic dermatitis (also known as eczema). The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from Lilly's Phase 3 studies, BRAVE-AA1 and BRAVE-AA2. The companies said Olumiant would be the first centrally-authorized oral treatment and first JAK inhibitor for patients with severe AA in the European Union, if approved by the European Commission (EC). The EC decision is expected in the next one to two months, the companies said in a May 20 release. The EC which generally makes a decision taking into account CHMP's opinion. AA is an autoimmune disorder which causes hair loss.
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Lilly, Incyte's Olumiant get EMA panel nod for hair loss disorder alopecia areata