The drug, a once-daily, oral, small molecule Janus kinase inhibitor, Rinvoq (upadacitinib) received approval from the US Food and Drug Administration (FDA) for the treatment of adults with rheumatoid arthritis (RA) that have had an inadequate response to methotrexate. It is not, however, indicated for methotrexate-naïve patients.
AbbVie stated it will list the drug at $59,000 (€53,187) per year.
Approval of Rinvoq comes after AbbVie’s Phase III program containing approximately 4,400 patients testing the efficacy, safety, and tolerability of the drug.
“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity – the primary treatment goals for RA,” said Roy Fleischmann, the primary investigator of the clinical trial.
Across the clinical program, rates of clinical remission, characterized by almost no disease activity and symptoms, were observed up to week 26.
Rinvoq is currently under review by the European Medicines Agency, as well as regulatory agencies in Canada and Japan.