CHMP Recommend Baricitinib for Approval in Europe Save

Eli Lilly and Company announced last friday 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 for the treatment of adults with moderate to severely active rheumatoid arthritis (RA) in those who have not responded to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs).

Baricitinib (also named Olumiant®) may be used as monotherapy or in combination with methotrexate.

This recommendation is the European equivalent to a positive vote by the Arthritis Advisory Committee to recomend drug approval to the FDA. Similar to the US and FDA, the final decision to approve baricitinib in the EU rests with the EMA.

The recommendation is  based on five phase 3 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.

Baricitinib is a once-daily oral, selective and reversible JAK1 and JAK2 inhibitor that is currently regulatory approval for use in RA in both the USA and EU. 

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.