By Michael Dabaie
Eli Lilly & Co. and Incyte said the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The opinion marks the first step toward European regulatory approval for baricitinib, marketed as Olumiant, for patients with atopic dermatitis.
The CHMP opinion is now being referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one to two months, the companies said.
Olumiant is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Lilly has exclusive worldwide development and commercialization rights for baricitinib and some follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.
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