The European Commission has granted marketing authorization for Olumiant (baricitinib) 4 mg and 2 mg tablets for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have an inadequate response to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). It is the first regulatory approval for Olumiant worldwide.
Olumiant is the first Janus kinase (JAK) inhibitor designed for the treatment of RA in the European Union (EU), and can be used alone or in combination with methotrexate. The drug was developed by Eli Lilly and Incyte, in an exclusive worldwide license and collaboration agreement announced in December 2009.
“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,” said Anthony J. Ware, MD, in a press release. Ware is senior vice president for product development and interim president of Eli Lilly Bio-medicines.
The regulatory submission to the European Commission was supported by a Phase 3 program, comprising four pivotal clinical trials assessing Olumiant. Eli Lilly and Incyte conducted the four trials (now completed) in a wide range of adult patients, from treatment-naïve adults to patients with inadequate responses to tumor necrosis factor (TNF) inhibitors.
Two of the four trials included pre-specified comparisons to previously approved DMARDs: one to methotrexate, RA-BEGIN (NCT01711359), and one to Humira (adalimumab), RA-BEAM (NCT01710358). In both trials, Olumiant demonstrated significant positive results by improving signs and symptoms of RA, compared to methotrexate and Humira.
“The European Commission’s approval of baricitinib is an exciting milestone for the RA community in the EU,” said Steven Stein, MD, Incyte’s chief medical officer. “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.”
After this European Commission approval, Incyte will become eligible to receive a milestone payment from Eli Lilly of $65 million.
The marketing authorization follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), announced in December 2016. That recommendation targeted those who failed to respond to, or were unable to tolerate DMARDs, such as Rheumatrex and Trexall.