New drug for moderate to severe active rheumatoid arthritis recommended for approval in Europe
Approval of baricitinib for people with moderate to severely active rheumatoid arthritis who responded inadequately to or are intolerant to a disease modifying anti-rheumatic drug, has been recommended by The European Medicine Agency’s Committee for Medicinal Products for Human Use.
“Bariticinib is the first Janus oral kinase (JAK) inhibitor to receive a positive Committee for Medicinal Products for Human Use opinion for the treatment of rheumatoid arthritis in the EU,” explains Andrew Hotchkiss, president of Eli Lilly’s European and Canadian operations. “It is an important milestone for people living with RA.”
The recommendation was based on five phase 3 trials and has been referred to the European Commission, which will make the final decision on marketing authorization within the next few months.
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