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European Commission Approves Baricitinib for Rheumatoid Arthritis
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The European Commission has granted marketing authorization to Eli Lilly and Company and Incyte Corporation for baricitinib — as 2-mg and 4-mg once-daily tablets — in the treatment of patients with moderate to severe rheumatoid arthritis who responded inadequately to or who are intolerant to disease-modifying antirheumatic drugs, according to a company press release.
“The European Commission’s approval of baricitinib is an exciting milestone for the [rheumatoid arthritis] RA community in the [European Union] E.U.,” Steven Stein, MD, chief medical officer of Incyte Corporation, said in the release. “We are confident that baricitinib will help to meet the needs of health care providers and their patients as they work toward achieving long-term treatment goals.”
Baricitinib (Olumiant, Lilly and Incyte) has become the first Janus oral kinase inhibitor to be approved to treat RA in the European Union. The phase 3 program for the drug included four completed clinical studies, two of which had a comparison against methotrexate and Humira by itself. As a result of the approval, Incyte is eligible to receive $65 million from Lilly, which it expects to receive in the first quarter of 2017.
“Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability,” J. Anthony Ware, MD, senior vice president for product development and interim president at Lilly Bio-Medicines, said in the release. “We believe that as a next-generation therapy in the E.U., Olumiant will advance RA treatment by helping patients with moderate to severe disease feel better quickly.”
Reference: https://investor.lilly.com/releasedetail.cfm?ReleaseID=1011661