AbbVie Gets FDA Nod for Rinvoq in Treating Giant Cell Arteritis

A daily dose of Rinvoq (upadacitinib) 15 mg from AbbVie now receives FDA approval for treating the severe autoimmune condition Giant Cell Arteritis (GCA) despite the lack of a cure while the disease progresses to threaten vision along with stroke and aortic aneurysm. Rinvoq gained approval from the U.S. shortly after the European Commission authorized the drug for adult GCA patients.

The FDA’s decision is based on robust results from the phase 3 SELECT-GCA trial, which demonstrated Rinvoq’s superior efficacy in achieving sustained remission. “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.

In a landscape where glucocorticoids are standard yet problematic due to toxicity and high relapse rates, Rinvoq offers a much-needed alternative. “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,” said Peter A. Merkel, M.D., MPH, SELECT-GCA investigator.

AbbVie has achieved this innovation while reinforcing its ongoing dedication to improving rheumatology healthcare since 2001. The pharmaceutical company is pursuing the development of new indications for Rinvoq and expanding its immunology leadership by targeting lupus and alopecia areata.