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."
GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. If left untreated, the disease can lead to debilitating symptoms and potentially severe outcomes, such as blindness, aortic aneurysm, or stroke. Caucasian women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing GCA. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.
"Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease," said Peter A. Merkel, M.D., MPH, chief of rheumatology at the University of Pennsylvania, Philadelphia, and SELECT-GCA trial investigator. "We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission."
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