Posted by Michael Wonder on 13 Feb 2017
European Commission approves once daily Olumiant tablets for treatment of adults with moderate to severe active rheumatoid arthritis
13 February 2017 - Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat rheumatoid arthritis in the EU.
Eli Lilly and Company and Incyte Corporation announced today that the European Commission has granted marketing authorisation for Olumiant (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
This is the first regulatory approval around the world for Olumiant -- the first JAK inhibitor approved to treat RA in the European Union -- which may be used as monotherapy or in combination with methotrexate. In clinical studies, Olumiant has demonstrated significant improvement in the signs and symptoms of RA compared to standard of care therapies such as methotrexate and Humira (adalimumab) with background methotrexate.
