USFDA approves AbbVie giant cell arteritis drug Rinvoq in adults
North Chicago, Ill.: AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for RINVOQ (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).
This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients.
The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission (46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002).
During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.
"This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "With this new indication for RINVOQ, we are underscoring AbbVie's commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases."
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