The European Medicine Agency’s Committee for Medicinal Products for Human Use has recommended approval of baricitinib for patients with moderate to severely active rheumatoid arthritis who responded inadequately to or are intolerant to a disease modifying anti-rheumatic drug.
If approved, the drug will be marketed as Olumiant from Eli Lilly and Company.
“Bariticinib is the first [Janus oral kinase] JAK inhibitor to receive a positive [Committee for Medicinal Products for Human Use] CHMP opinion for the treatment of [rheumatoid arthritis] RA in the [European Union] EU,” Andrew Hotchkiss, president of Eli Lilly’s European and Canadian operations, said in a company press release. “It is an important milestone for people living with RA.”
The $65 million milestone payment from Eli Lilly to Incyte that was supposed to occur after CHMP’s recommendation will now occur after the EU Commission grants marketing authorization, according to a recent amendment in the agreement between the companies.
CHMP’s positive opinion — which was based on five phase 3 trials — has been referred to the European Commission, who will make the final decision on marketing authorization.
“The positive opinion for baricitinib paves the way for adults with rheumatoid arthritis to be offered a new treatment option,” Steven Stein, MD, chief medical officer of Incyte, said in the release. “Incyte is proud to have partnered with Lilly on the research and development of this promising medicine, and we are pleased that the CHMP positive opinion brings us one step closer to providing baricitinib to the many people living with this chronic condition.”