Canada & E.U. Approve Upadacitinib for RA

Upadacitinib (Rinvoq) is a once daily, selective and reversible JAK inhibitor that can be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).

In January 2020, Health Canada announced the approval of upadacitinib for treating patients with moderate to severe active rheumatoid arthritis (RA) who have experienced an inadequate response or are intolerant to methotrexate. According to a Health Canada report, approximately one in every 100 Canadian adults (~300,000 patients) live with RA, the majority of whom may not achieve remission. This approval gives patients more treatment options.¹

Additionally in late December 2019, the European Commission approved upadacitinib to treat adults with moderate to severe active RA who have experienced an inadequate response to or are intolerant to one or more DMARDs.² The treatment has been approved as a once daily dose of 15 mg in both Canada and the E.U.

The Research
These approvals were based on data from the global Phase 3 SELECT RA program. In this program, approximately 4,400 patients with moderate to severe active RA were evaluated in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY. The studies assessed the efficacy, safety and tolerability of upadacitinib in different varieties of patients. Participants included patients who were methotrexate naive, had experienced an inadequate response to methotrexate or biologic DMARDs, and/or were intolerant to biologic DMARDs. In these studies, upadacitinib met all the primary endpoints.

The results of these studies were also used to garner U.S. Food and Drug Administration approval.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. AbbVie Canada. News release: AbbVie receives health canada approval of Rinvoq (upadacitinib), an oral medication for the treatment of adults with moderate to severe active rheumatoid arthritis. FirstWord Pharma. 2020 Jan 7.
2. AbbVie. News release: AbbVie receives European Commission approval of Rinvoq (upadacitinib) for the treatment of adults with moderate to severe active rheumatoid arthritis. FirstWord Pharma. 2019 Dec 18.