Abbvie’s RINVOQ Wins EC Approval

AbbVie received approval from the European Commission for RINVOQ (upadacitinib) 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 (DMARDs). RINVOQ is a once-daily selective and reversible JAK inhibitor and may be used as monotherapy or in combination with methotrexate (MTX).

“We are proud to offer this once-daily tablet as a new treatment option for patients with moderate to severe active rheumatoid arthritis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “As a company that has been dedicated to discovering and delivering transformative therapies for people living with rheumatic diseases for nearly two decades, RINVOQ expands our portfolio of treatment options for people living with this disease in Europe.”

The approval was supported by data from the global Phase 3 SELECT rheumatoid arthritis program, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies that assessed efficacy, safety and tolerability across a variety of patients, including those who failed or were intolerant to biologic DMARDs and who were naïve or inadequate responders (IR) to MTX.