AbbVie Receives FDA Approval for New Rheumatoid Arthritis Treatment
AbbVie’s Rinvoq (upadacitinib) received FDA approval on Friday for treating moderate to severe rheumatoid arthritis in adults.
The potential blockbuster drug is an 15mg, once-daily oral janus kinase inhibitor used to treat adults with moderate or severe RA that reacted poorly or are intolerant to methotrexate, a drug commonly used in treating the inflammatory disorder.
The FDA’s approval was based on the results of five phase 3 clinical trials that evaluated approximately 4,400 patients. The studies assessed efficacy, safety and intolerability across a variety of RA patients, including ones who failed or did not tolerate biologic disease-modifying anti-rheumatic drugs.
AbbVie plans to release Rinvoq in the U.S. this month. Rinvoq is currently being reviewed by the EMA, as well as regulatory authorities in Canada and Japan.