CHMP recommends Olumiant (baricitinib) to treat moderate to severe RA.- Eli Lilly

Eli Lilly and Company and Incyte Corporation announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (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 (DMARDs). 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 authorization within two to three months of the CHMP issuing its recommendation. Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU.

The CHMP positive opinion was based on five phase III clinical trials of baricitinib in adult patients with moderate to severe active rheumatoid arthritis (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND). A wide range of patients participated in the clinical trial program, including those who are inadequate responders to methotrexate, inadequate responders to conventional synthetic disease modifying anti rheumatic drugs (csDMARDs), or inadequate responders to biological disease modifying anti rheumatic drugs (bDMARDs) including TNF inhibitors.