Posted by Michael Wonder on 18 Oct 2019
AbbVie receives CHMP positive opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe active rheumatoid arthritis
18 October 2019 - CHMP positive opinion, supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more than 4,400 patients, will now be referred to the European Commission for final approval.
AbbVie today announced that the EMA CHMP adopted a positive opinion for Rinvoq (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
The positive opinion is for use of upadacitinib as monotherapy or in combination with methotrexate.
