European Commission approves Lilly’s and Incyte’s rheumatoid arthritis drug

Eli Lilly and Incyte Corporation have won European Commission’s marketing authorisation for Olumiant (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

This is the first regulatory approval for Olumiant and the first JAK inhibitor approved to treat RA in the European Union which may be used as monotherapy or in combination with methotrexate, the company noted.

The approval will trigger $65 million milestone payment to Incyte from Lilly. The payment will be recorded in the first quarter of 2017.