FDA approves RINVOQ for giant cell arteritis treatment

NORTH CHICAGO, Ill. - AbbVie (NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $340 billion, announced today that the U.S. Food and Drug Administration (FDA) has approved its drug RINVOQ (upadacitinib) for the treatment of adults with giant cell arteritis (GCA). According to InvestingPro data, the company maintains strong financials with revenues of $57.4 billion and an impressive gross profit margin of 71%. This approval positions RINVOQ as the first and only oral Janus Kinase (JAK) inhibitor for GCA treatment in the U.S.

The FDA’s decision is supported by the Phase 3 SELECT-GCA clinical trial results, which demonstrated that 46.4% of patients treated with RINVOQ achieved sustained remission from week 12 to week 52 compared to 29.0% receiving a placebo, both in combination with a steroid taper regimen. This approval could further strengthen AbbVie’s market position, with InvestingPro analysts already projecting net income growth for the current year.

GCA, also known as temporal arteritis, is the most prevalent form of vasculitis in Western countries, affecting adults’ cranial arteries and potentially leading to serious health complications, including blindness and stroke. The disease most commonly occurs in Caucasian women over the age of 50.

Dr. Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, stated that the FDA approval offers an alternative treatment option that can help patients achieve sustained remission while tapering off steroids.

The safety profile of RINVOQ during the trial was consistent with that observed in other indications for which the drug is approved. However, RINVOQ may cause serious side effects, including serious infections, increased risk of death in older individuals with heart disease risk factors, cancer, major cardiovascular events, blood clots, and serious allergic reactions.

AbbVie has also established a patient support program and offers a co-pay card to reduce out-of-pocket costs for eligible patients. Uninsured patients or those unable to afford their medication may qualify for AbbVie’s Patient Assistance Program, myAbbVieAssist.

RINVOQ is being studied in various immune-mediated inflammatory diseases, and its efficacy in other conditions is currently under investigation in Phase 3 clinical trials.

This news is based on a press release statement from AbbVie. For investors seeking deeper insights, InvestingPro offers comprehensive analysis with 12+ additional ProTips and a detailed research report, helping you make informed investment decisions based on AbbVie’s financial health, market position, and growth prospects.

In other recent news, AbbVie has reported impressive financial results for the first quarter of 2025, surpassing Wall Street expectations. The company achieved an adjusted earnings per share (EPS) of $2.46, exceeding the forecasted $2.39, and reported revenues of $13.3 billion, which were $550 million above projections. Key drivers of this performance included strong sales of their immunology drugs, Skyrizi and Rinvoq, which offset a decline in sales of Humira. AbbVie also raised its full-year EPS guidance to between $12.09 and $12.29, indicating confidence in its growth strategy. In terms of analyst activity, BMO Capital Markets maintained an Outperform rating for AbbVie, with a price target of $215, highlighting the company’s robust performance and strategic execution. The company’s neuroscience portfolio also saw significant growth, with Vyalev demonstrating an initial growth rate of 80%, surpassing forecasts. Additionally, AbbVie plans to invest $10 billion in U.S. manufacturing over the next decade to support its expansion. These developments underscore AbbVie’s strategic focus on diversification and innovation within its portfolio.

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