Eli Lilly and Incyte have secured marketing authorisation approval for Olumiant (baricitinib) 4mg and 2mg film-coated tablets from the European Commission (EC) to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients.
Olumiant is a JAK inhibitor that has been approved to treat RA in the European Union and may be used as monotherapy or in combination with methotrexate.
In clinical studies, the drug has demonstrated improvement in the signs and symptoms of RA compared to standard of care therapies such as methotrexate and Humira (adalimumab) with background methotrexate.
Lilly bio-medicines product development and interim president senior vice-president Anthony Ware said: "Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability.
"We believe that as a next-generation therapy in the EU, Olumiant will advance RA treatment by helping patients with moderate-to-severe disease feel better quickly."
The Phase III programme of Baricitinib's includes four completed clinical studies in adult patients with RA.
Two of the studies, RA-BEGIN and RA-BEAM, included a pre-specified comparison against either methotrexate or Humira with background methotrexate.
Incyte chief medical officer Dr Steven Stein said: "The European Commission's approval of baricitinib is an exciting milestone for the RA community in the EU.
"We're confident that baricitinib will help to meet the needs of healthcare providers and their patients as they work toward achieving long-term treatment goals."
Following the approval of Olumiant by the EC, Incyte is eligible to receive $65m from Lilly.
The once-daily oral, selective and reversible JAK1 and JAK2 inhibitor Baricitinib is currently in clinical studies for inflammatory and autoimmune diseases.
Image: Severe arthritis in a hand that was not treated. Photo: courtesy of James Heilman, MD.