FDA Approves Updated Indication for AbbVie’s RINVOQ® (upadacitinib) Expanding Access for Patients with Inflammatory Bowel Disease
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) updating the indication statement for RINVOQ® (upadacitinib) in the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD).
The new approval marks an important advancement in AbbVie’s inflammatory bowel disease (IBD) portfolio, broadening treatment eligibility for patients who may not be suitable candidates for tumor necrosis factor (TNF) blockers.
Expanding Access for IBD Patients
Previously, RINVOQ was indicated only for adults with moderately to severely active UC or CD who had demonstrated an inadequate response or intolerance to one or more TNF blockers. The updated FDA label now allows physicians to prescribe RINVOQ to patients who have received at least one approved systemic therapy, in cases where TNF blockers are considered clinically inadvisable by the treating healthcare provider.
This expanded indication gives clinicians greater flexibility to tailor treatment decisions based on each patient’s unique medical profile and disease trajectory.
At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease,” said Dr. Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie. “UC and Crohn’s disease can impact nearly every aspect of a patient’s life. This label update gives healthcare providers the ability to prescribe RINVOQ for patients with moderately to severely active IBD following the use of one systemic therapy, when TNF blockers are deemed clinically inadvisable.”
Understanding Inflammatory Bowel Disease (IBD)
Inflammatory bowel disease (IBD) refers to a group of chronic, immune-mediated disorders characterized by inflammation of the gastrointestinal (GI) tract. The two most common forms—Crohn’s disease (CD) and ulcerative colitis (UC)—are progressive and can cause debilitating symptoms that significantly impair quality of life.
In Crohn’s disease, inflammation can affect any part of the GI tract but most frequently targets the area between the small intestine (ileum) and colon. This often leads to persistent diarrhea, abdominal pain, and fatigue.
Ulcerative colitis, by contrast, involves continuous inflammation of the colon and rectum, resulting in bloody diarrhea, rectal bleeding, tenesmus (the sensation of incomplete evacuation), and abdominal discomfort. Both diseases are marked by unpredictable flare-ups and remissions that impose substantial physical, emotional, and economic burdens on patients.
Over time, chronic inflammation can lead to complications requiring surgery or hospitalization, emphasizing the need for new therapeutic options that provide durable control of symptoms and inflammation.
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective Janus kinase (JAK) inhibitor designed to target key pathways involved in the inflammatory process. In laboratory studies, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated primarily by JAK1 and JAK1/JAK3. The relevance of specific JAK inhibition to clinical efficacy and safety continues to be evaluated.
Beyond IBD, RINVOQ is being studied in multiple immune-mediated inflammatory diseases, including:
- Alopecia areata
- Hidradenitis suppurativa
- Takayasu arteritis
- Systemic lupus erythematosus
- Vitiligo
This broad development program underscores AbbVie’s long-term commitment to advancing novel immunology solutions across disease areas.
RINVOQ: U.S. Approved Indications
RINVOQ (upadacitinib) is approved in the United States to treat a wide range of inflammatory and autoimmune diseases, including:
- Rheumatoid arthritis (RA): Adults with moderate to severe RA after inadequate response or intolerance to TNF blockers.
- Psoriatic arthritis (PsA) and ankylosing spondylitis (AS): Adults with active disease after TNF therapy failure.
- Non-radiographic axial spondyloarthritis (nr-axSpA): Adults with objective signs of inflammation after TNF therapy.
- Giant cell arteritis (GCA): Adults with active disease.
- Ulcerative colitis (UC) and Crohn’s disease (CD): Adults with moderate to severe disease who have used one or more TNF blockers without success or intolerance, or following at least one systemic therapy when TNF blockers are not recommended.
- Atopic dermatitis (AD): Adults and adolescents (12 years and older) with moderate to severe eczema inadequately controlled by other systemic therapies.
- Polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (PsA): Children aged 2 years and older after failure of TNF blockers.
Important Safety Information for RINVOQ
Like other JAK inhibitors, RINVOQ carries important safety considerations. The medication may cause serious side effects, including:
- Serious infections such as tuberculosis (TB), bacterial, fungal, or viral infections, some of which have been fatal.
- Increased risk of death in individuals aged 50 years and older with at least one cardiovascular (CV) risk factor.
- Cancers and immune system problems, including a higher risk of lymphoma and skin cancer, particularly in current or past smokers.
- Major cardiovascular events such as heart attack, stroke, or CV-related death, especially in individuals over 50 with CV risk factors.
- Blood clots (venous or arterial), which may be fatal and are more likely in older adults with CV risk factors.
- Serious allergic reactions including swelling, hives, and difficulty breathing.
- Gastrointestinal perforations (tears in the stomach or intestines), especially among patients taking NSAIDs or corticosteroids.
Healthcare providers are advised to test for tuberculosis before initiating RINVOQ, monitor laboratory parameters throughout treatment, and avoid live vaccines during therapy.
Patients should report any signs of infection, unexplained chest pain, shortness of breath, or sudden vision changes immediately to their healthcare provider.
For comprehensive safety information, patients can review the Full Prescribing Information and Medication Guide available at RINVOQ.com.
Patient Access and Support Programs
AbbVie remains committed to ensuring patients can access RINVOQ through multiple affordability programs. Eligible, commercially insured patients may qualify for co-pay assistance, potentially reducing their out-of-pocket costs to $0 per month.
For those who are uninsured or unable to afford their medications, AbbVie offers the myAbbVieAssist Patient Assistance Program, which provides medication access based on financial need. Full details are available at abbvie.com/PatientAccessSupport.
AbbVie’s Commitment to Immunology Innovation
With a robust immunology portfolio that includes RINVOQ, SKYRIZI® (risankizumab), and an expanding pipeline of next-generation therapies, AbbVie continues to advance its leadership in addressing immune-mediated diseases.
The FDA’s updated indication for RINVOQ reinforces AbbVie’s dedication to expanding treatment choices for patients with ulcerative colitis and Crohn’s disease—chronic conditions that profoundly affect millions worldwide. By providing more flexible prescribing options, AbbVie aims to help healthcare providers individualize treatment plans that optimize long-term disease control and improve quality of life for patients living with IBD.
This press release includes forward-looking statements regarding AbbVie’s products and research programs. Actual results may differ materially depending on various factors, including regulatory developments, clinical outcomes, and market conditions.FDA Approves Updated Indication for AbbVie’s RINVOQ® (upadacitinib) Expanding Access for Patients with Inflammatory Bowel Disease
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) updating the indication statement for RINVOQ® (upadacitinib) in the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD).
The new approval marks an important advancement in AbbVie’s inflammatory bowel disease (IBD) portfolio, broadening treatment eligibility for patients who may not be suitable candidates for tumor necrosis factor (TNF) blockers.
Expanding Access for IBD Patients
Previously, RINVOQ was indicated only for adults with moderately to severely active UC or CD who had demonstrated an inadequate response or intolerance to one or more TNF blockers. The updated FDA label now allows physicians to prescribe RINVOQ to patients who have received at least one approved systemic therapy, in cases where TNF blockers are considered clinically inadvisable by the treating healthcare provider.
This expanded indication gives clinicians greater flexibility to tailor treatment decisions based on each patient’s unique medical profile and disease trajectory.
“At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease,” said Dr. Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie. “UC and Crohn’s disease can impact nearly every aspect of a patient’s life. This label update gives healthcare providers the ability to prescribe RINVOQ for patients with moderately to severely active IBD following the use of one systemic therapy, when TNF blockers are deemed clinically inadvisable.”
Understanding Inflammatory Bowel Disease (IBD)
Inflammatory bowel disease (IBD) refers to a group of chronic, immune-mediated disorders characterized by inflammation of the gastrointestinal (GI) tract. The two most common forms—Crohn’s disease (CD) and ulcerative colitis (UC)—are progressive and can cause debilitating symptoms that significantly impair quality of life.
In Crohn’s disease, inflammation can affect any part of the GI tract but most frequently targets the area between the small intestine (ileum) and colon. This often leads to persistent diarrhea, abdominal pain, and fatigue.
Ulcerative colitis, by contrast, involves continuous inflammation of the colon and rectum, resulting in bloody diarrhea, rectal bleeding, tenesmus (the sensation of incomplete evacuation), and abdominal discomfort. Both diseases are marked by unpredictable flare-ups and remissions that impose substantial physical, emotional, and economic burdens on patients.
Over time, chronic inflammation can lead to complications requiring surgery or hospitalization, emphasizing the need for new therapeutic options that provide durable control of symptoms and inflammation.
About RINVOQ® (upadacitinib
Discovered and developed by AbbVie scientists, RINVOQ is a selective Janus kinase (JAK) inhibitor designed to target key pathways involved in the inflammatory process. In laboratory studies, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated primarily by JAK1 and JAK1/JAK3. The relevance of specific JAK inhibition to clinical efficacy and safety continues to be evaluated.
Beyond IBD, RINVOQ is being studied in multiple immune-mediated inflammatory diseases, including:
- Alopecia areata
- Hidradenitis suppurativa
- Takayasu arteritis
- Systemic lupus erythematosus
- Vitiligo
This broad development program underscores AbbVie’s long-term commitment to advancing novel immunology solutions across disease areas.
RINVOQ: U.S. Approved Indications
RINVOQ (upadacitinib) is approved in the United States to treat a wide range of inflammatory and autoimmune diseases, including:
- Rheumatoid arthritis (RA): Adults with moderate to severe RA after inadequate response or intolerance to TNF blockers.
- Psoriatic arthritis (PsA) and ankylosing spondylitis (AS): Adults with active disease after TNF therapy failure.
- Non-radiographic axial spondyloarthritis (nr-axSpA): Adults with objective signs of inflammation after TNF therapy.
- Giant cell arteritis (GCA): Adults with active disease.
- Ulcerative colitis (UC) and Crohn’s disease (CD): Adults with moderate to severe disease who have used one or more TNF blockers without success or intolerance, or following at least one systemic therapy when TNF blockers are not recommended.
- Atopic dermatitis (AD): Adults and adolescents (12 years and older) with moderate to severe eczema inadequately controlled by other systemic therapies.
- Polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (PsA): Children aged 2 years and older after failure of TNF blockers.
Important Safety Information for RINVOQ
Like other JAK inhibitors, RINVOQ carries important safety considerations. The medication may cause serious side effects, including:
- Serious infections such as tuberculosis (TB), bacterial, fungal, or viral infections, some of which have been fatal.
- Increased risk of death in individuals aged 50 years and older with at least one cardiovascular (CV) risk factor.
- Cancers and immune system problems, including a higher risk of lymphoma and skin cancer, particularly in current or past smokers.
- Major cardiovascular events such as heart attack, stroke, or CV-related death, especially in individuals over 50 with CV risk factors.
- Blood clots (venous or arterial), which may be fatal and are more likely in older adults with CV risk factors.
- Serious allergic reactions including swelling, hives, and difficulty breathing.
- Gastrointestinal perforations (tears in the stomach or intestines), especially among patients taking NSAIDs or corticosteroids.
Healthcare providers are advised to test for tuberculosis before initiating RINVOQ, monitor laboratory parameters throughout treatment, and avoid live vaccines during therapy.
Patients should report any signs of infection, unexplained chest pain, shortness of breath, or sudden vision changes immediately to their healthcare provider.
For comprehensive safety information, patients can review the Full Prescribing Information and Medication Guide available at RINVOQ.com.
Patient Access and Support Program
AbbVie remains committed to ensuring patients can access RINVOQ through multiple affordability programs. Eligible, commercially insured patients may qualify for co-pay assistance, potentially reducing their out-of-pocket costs to $0 per month.
For those who are uninsured or unable to afford their medications, AbbVie offers the myAbbVieAssist Patient Assistance Program, which provides medication access based on financial need. Full details are available at abbvie.com/PatientAccessSupport.
AbbVie’s Commitment to Immunology Innovation
With a robust immunology portfolio that includes RINVOQ, SKYRIZI® (risankizumab), and an expanding pipeline of next-generation therapies, AbbVie continues to advance its leadership in addressing immune-mediated diseases.
The FDA’s updated indication for RINVOQ reinforces AbbVie’s dedication to expanding treatment choices for patients with ulcerative colitis and Crohn’s disease—chronic conditions that profoundly affect millions worldwide. By providing more flexible prescribing options, AbbVie aims to help healthcare providers individualize treatment plans that optimize long-term disease control and improve quality of life for patients living with IBD.
