Lilly/Incyte’s rheumatoid arthritis drug gets CHMP’s recommendation for EMA’s approval

Eli Lilly and Incyte Corporation have gotten positive opinion from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), for baricitinib – which if approved would be marketed as Olumiant.

Baricitinib would be indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate, explained Lilly in its press release issued on Friday.

This is the first regulatory step towards the approval of baricitinib and the CHMP positive opinion is referred for final action to the European Commission, which grants approval in the EU.

Andrew Hotchkiss, president of Lilly’s European and Canadian operations said that there is no cure for rheumatoid arthritis and although improvements have been seen in the long term outcomes for patients, not all people reach low disease activity or remission.

Hotchkiss also noted that Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU.

The $65 million milestone payment that was to be paid by Lilly to Incyte upon positive CHMP opinion will now be triggered by the granting of marketing authorization by the EU Commission per a recent amendment to the parties’ Agreement.