European Commission Approves Once-Daily Tablets for Rheumatoid Arthritis

The European Commission has approved the use of baricitinib (Olumiant) 2 mg and 4 mg film-coated tablets for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who show inadequate response to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).

Baricitinib may be used alone or in combination with methotrexate. The drug, developed by Eli Lilly and Incyte Corporation, is the first Januse kinase (JAK) inhibitor authorized to treat RA in the European Union. Clinical studies showed that the drug improved signs and symptoms of RA compared with standard therapies, including adalimumab.

Baricitinib’s Phase III program includes five clinical trials in adults with RA including patients who are inadequate responders to methotrexate and other cDMARDs and those who are inadequate responders to TNF inhibitors. One of those studies included a pre-specified comparison against adalimumab.

Steven Stein, MD, chief medical officer of Incyte Corporation noted that the European Commission’s approval of baricitinib is a significant milestone in the treatment of RA in Europe. As a result of this milestone, Incyte will receive a payment of $65 million from Lilly.

Baricitinib is a once-daily oral, selective, and reversible JAK1 and JAK2 inhibitor. In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib. The drug was submitted for regulatory review for the treatment of rheumatoid arthritis in the US, European Union, and Japan in the first quarter of 2016.

Source: Eli Lilly