• Approval based on Phase 3 SELECT, in which drugs evaluated in 4,400 patients
• In five Phase 3 trials, Rinvoq has met all the primary and secondary endpoints
• Rinvoq showed low disease activity and clinical remission
The European Commission approved Rinvoq (upadacitinib) for moderate to severely active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The drug is a JAK inhibitor, which is indicated in combination or methotrexate. The drug is administered once daily.
"We are proud to offer this once-daily tablet as a new treatment option for patients with moderate to severely active rheumatoid arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie.
Also read: Rinvoq approved in US
The approval was based on five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, and SELECT-EARLY. In the trials, the drug was tested in patients who failed or were intolerant to biologic DMARDs, naïve, or inadequate responders to IR.
About Phase 3 SELECT program
SELECT COMPARE in MTX-IR patients: Rinvoq + MTX showed higher remission rates vs placebo + MTX and Humira + MTX
SELECT MONOTHERAPY in MTX-IR patients: Rinvoq achieved higher remission than MTX alone
SELECT EARLY in MTX-naïve patients: Rinvoq achieved higher remission than MTX alone
The drug has already approved in the United States by the Food and Drug Administration, who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The drug is administered once daily, either as monotherapy or with combinations.