European regulators have taken a key step toward approving baricitinib to treat those with moderate to severe rheumatoid arthritis (RA).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Eli Lilly and Company be able to market baricitinib under its brand name Olumiant. The European Commission will make the final decision on the matter.
Baricitinib is a Janus oral kinase (JAK) 1 and 2 inhibitor. Janus kinases are enzymes that transmit important cell signals. The signals deal with a number of proteins known as cytokines and growth factors in blood-cell formation, inflammation and immune function.
Baricitinib is recommended for those who failed to respond to, or were unable to tolerate, disease-modifying anti-rheumatic drugs (DMARDs) such as Rheumatrex and Trexall.
If approved, Olumiant will be available as 2-mg or 4-mg film-coated tablets.
Clinical trials that led to CHMP’s recommendation — including RA-BUILD (NCT01721057) and RA-BEAM (NCT01710358) — indicated that the most common side effects of baricitinib were increased LDL or “bad” cholesterol, upper respiratory tract infections and nausea.
Baricitinib may be used by itself or in combination with methotrexate to treat rheumatoid arthritis, according to the Arthritis Foundation. Methotrexate is one of the most effective, safest and widely used medications for treating RA.
“Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU,” Andrew Hotchkiss, president of Eli Lilly’s operations in the EU and Canada, said in a press release. “It is an important milestone for people living with RA.”
Eli Lilly and Incyte formed a partnership in 2009 to develop and market baricitinib globally as a treatment for inflammatory and autoimmune diseases. Under amended terms of the deal, Eli Lilly will give Incyte a $65-million up-front payment after the European Commission grants marketing authorization to the drug.
“The positive opinion for baricitinib paves the way for adults with rheumatoid arthritis to be offered a new treatment option,” said Steven Stein, MD, chief medical officer of Incyte. “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.”