Dec. 16, 2016
Eli Lilly and Company and Incyte Corporation have announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued a positive opinion recommending the approval of baricitinib – which if approved, would be marketed as Olumiant®. Baricitinib is recommended to be used for treating moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate. This recommendation from CHMP is expected to be followed by the approval from the European Commission, who will make the decision on marketing authorization.
Andrew Hotchkiss, president of Lilly’s European and Canadian operations, said: “Rheumatoid arthritis is a debilitating disease and can have a devastating impact on a person’s quality of life. There is no cure for rheumatoid arthritis and although improvements have been seen in the long-term outcomes for patients, not all people reach low disease activity or remission. Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU. It is an important milestone for people living with rheumatoid arthritis and Lilly is committed to improving outcomes for people living with this chronic condition.”
“The positive opinion for baricitinib paves the way for adults with rheumatoid arthritis to be offered a new treatment option. Incyte is proud to have partnered with Lilly on the research and development of this promising medicine, and we are pleased that the CHMP positive opinion brings us one step closer to providing baricitinib to the many people living with this chronic condition,” said Steven Stein, M.D., chief medical officer, Incyte Corporation.