RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA)

Rhea-AI Summary

AbbVie's RINVOQ (upadacitinib) has received FDA approval as the first oral JAK inhibitor for treating giant cell arteritis (GCA) in adults. This marks RINVOQ's ninth approved indication in the U.S., following recent European Commission authorization.

The approval is based on the Phase 3 SELECT-GCA trial results, where 46.4% of patients using RINVOQ 15mg with a 26-week steroid taper achieved sustained remission, compared to 29% in the placebo group. The drug's safety profile remained consistent with previous indications.

GCA is an autoimmune disease affecting cranial arteries, primarily impacting Caucasian women over 50. If untreated, it can lead to severe outcomes including blindness and stroke. RINVOQ offers an alternative to traditional steroid treatment, though it may cause serious side effects including infections, blood clots, and increased risk of major cardiovascular events in certain patients.

Positive

• FDA approval for RINVOQ in GCA marks the ninth approved indication, expanding market potential
• First and only oral JAK inhibitor approved for GCA treatment, creating a competitive advantage
• Strong clinical trial results with 46.4% of patients achieving sustained remission vs 29% for placebo
• Recent European Commission approval adds to global market reach
• Safety profile consistent with other approved indications, reducing regulatory risks

Negative

• Significant safety risks including serious infections, increased death risk in certain populations
• Higher cancer and cardiovascular event risks may limit market adoption
• Competition from established glucocorticoid treatments in GCA therapy
• Safety concerns particularly high for patients over 50 with heart disease risk factors

–      RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults
–      Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries²
–      This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology¹

NORTH CHICAGO, Ill., April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ^® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).¹ 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).¹

During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.¹ 

"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.² 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.⁴ 

"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."

RINVOQ SAFETY CONSIDERATIONS

• RINVOQ may cause serious side effects, including:
  • Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
  • Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
  • Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
  • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
  • Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
  • Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
  • Tears in the stomach or intestines; changes in certain laboratory test results.

*Sustained remission was defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined corticosteroid taper regimen.

For more information about RINVOQ, visit RINVOQ.com.

About SELECT-GCA 
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib (RINVOQ) in 428 patients with GCA. The study consists of two periods. The first period, previously reported in April 2024, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.¹ For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).

About Giant Cell Arteritis  
Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.^2,3 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.² It is the most common vasculitis affecting adults in Western countries.²

Patient Access & Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to $0 per month for eligible, commercially insured patients. Patients who are uninsured, or who are otherwise unable to pay for their medication, may be eligible for AbbVie's Patient Assistance Program, myAbbVieAssist, at https://www.abbvie.com/PatientAccessSupport.

About RINVOQ^® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation.¹ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.^5-9 

RINVOQ (upadacitinib) U.S. Uses and Important Safety Information¹

RINVOQ is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
• Adults with giant cell arteritis (GCA).
• Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.

RINVOQ/RINVOQ LQ is a prescription medicine used to treat:

• Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis.  

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

What is the most important information I should know about RINVOQ*?

RINVOQ may cause serious side effects, including:

• Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
• Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
• Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
• Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
• Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
• Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
• Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
• Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

• Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as:
  • Fever, sweating, or chills
  • Shortness of breath
  • Warm, red, or painful skin or sores on your body
  • Muscle aches
  • Feeling tired
  • Blood in phlegm
  • Diarrhea or stomach pain
  • Cough
  • Weight loss
  • Burning when urinating or urinating more often than normal
• Have TB or have been in close contact with someone with TB.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
• Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
• Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
• Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
• There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
• Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

What should I do or tell my HCP AFTER starting RINVOQ?

• Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
• Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
  • Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
  • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • Pain or discomfort in your arms, back, neck, jaw, or stomach
  • Shortness of breath with or without chest discomfort
  • Breaking out in a cold sweat
  • Nausea or vomiting
  • Feeling lightheaded
  • Weakness in one part or on one side of your body
  • Slurred speech
• Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
  • Swelling
  • Pain or tenderness in one or both legs
  • Sudden unexplained chest or upper back pain
  • Shortness of breath or difficulty breathing
• Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.

These are not all the possible side effects of RINVOQ.

How should I take RINVOQ/RINVOQ LQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.

*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.

This is the most important information to know about RINVOQ. For more information, talk to your HCP. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. 

Please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. 

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

US-RNQR-250186

References:

1. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025.
2. Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis (temporal arteritis). Updated August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459376/
3. Weyand CM, Goronzy JJ. Immunology of giant cell arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128
4. Giant cell arteritis. Arthritis Foundation. Accessed January 15, 2025. https://www.arthritis.org/diseases/giant-cell-arteritis. 
5. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed January 15, 2025.
6. Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed January 15, 2025.
7. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed January 15, 2025.
8. A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed January 15, 2025.
9. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed January 15, 2025.

U.S. Media: Karen May +1 (773) 415-2065 Karen.may@abbvie.com

Investors: Liz Shea +1 (847) 935-2211 liz.shea@abbvie.com

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SOURCE AbbVie

FAQ

What is RINVOQ's new FDA approval for ABBV and why is it significant?

RINVOQ received FDA approval for treating giant cell arteritis (GCA) in adults, making it the first and only oral JAK inhibitor approved for this condition. This marks RINVOQ's ninth approved indication for AbbVie (ABBV), expanding its treatment portfolio across rheumatology, gastroenterology, and dermatology.

How effective was RINVOQ in treating GCA in AbbVie's clinical trials?

In the Phase 3 SELECT-GCA trial, 46.4% of patients receiving RINVOQ 15 mg with a 26-week steroid taper achieved sustained remission from week 12 to week 52, compared to 29.0% in the placebo group with a 52-week steroid taper (p=0.002).

What are the main safety concerns for RINVOQ treatment?

Key safety concerns include serious infections, increased risk of death in people over 50 with heart disease risk factors, cancer and immune system problems, cardiovascular events, blood clots, serious allergic reactions, and potential stomach or intestinal tears.

Who is most affected by Giant Cell Arteritis (GCA) that RINVOQ treats?

GCA primarily affects Caucasian women over 50, with highest risk between ages 70-80. While women are more likely to develop GCA, men tend to experience more ocular manifestations of the disease.

What makes RINVOQ different from existing GCA treatments?

RINVOQ offers an alternative to traditional glucocorticoid treatment, allowing patients to taper off steroids while achieving sustained remission. It's the first oral JAK inhibitor approved for GCA, providing a new treatment option for this autoimmune disease.