Posted by Michael Wonder on 17 Dec 2016
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe active rheumatoid arthritis
16 December 2016 - Eli Lilly and Company and Incyte Corporation announced today that the EMA's CHMP has issued a positive opinion, recommending the approval of baricitinib - which if approved would be marketed as Olumiant.
Baricitinib would be indicated for the treatment of 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. Baricitinib may be used as monotherapy or in combination with methotrexate.
This is the first regulatory step towards the approval of baricitinib and the CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU. The Commission usually makes a decision on marketing authorisation within two to three months of the CHMP issuing its recommendation.
