FDA’s approval of AbbVie’s upadacitinib (Rinvoq) to treat rheumatoid arthritis (RA) is expected to help the pharma maker stem its losses from future biosimilar competition to adalamumib (Humira).
The 15 mg once-daily oral tablet was approved to treat adults with severely active RA who have had an inadequate response or intolerance to methotrexate (MTX-IR).
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AbbVie’s Humira, which treats RA, ulcerative colitis, and a number of other inflammatory conditions, will face biosimilar competition in 2023. The blockbuster drug produced 61% of AbbVie's total revenue in 2018, Investor’s Business Daily reported.
Rinvoq will also help AbbVie compete against other RA blockbusters, including Pfizer’s tofacitinib (Xeljanz) and Lilly/ Incyte’s baracitinib (Olumiant).
"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 rheumatoid arthritis," said Roy M. Fleischmann, MD, primary investigator for the SELECT-COMPARE trial and clinical professor at the University of Texas Southwestern Medical Center at Dallas, in an AbbVie statement. ”With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal."
FDA’s approval of Rinvoq is supported by data from one of the largest registrational phase 3 programs in RA, according to AbbVie. Around 4,400 patients were evaluated across all treatment arms in 5 studies.
In SELECT-EARLY, 52% of MTX-naïve patients treated with Rinvoq 15 mg. achieved ACR50 versus 28% treated with MTX at week 12. In SELECT-MONOTHERAPY, 68% of MTX-IR patients treated with Rinvoq 15 mg. achieved ACR20 vs 41% treated with continued MTX at week 14.