NORTH CHICAGO, Ill., July 16, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has failed to meet the action date of the Prescription Drug User Fee Act (PDUFA) for the supplemental New Drug Application (sNDA) for RINVOQ® (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
In accordance with the recent update on the PDUFA action data for RINVOQ in psoriatic arthritis and ankylosing spondylitis, the FDA cited its ongoing review of Pfizer’s post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.
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No formal regulatory action has been taken regarding the sNDAs for RINVOQ in atopic dermatitis, psoriatic arthritis, or ankylosing spondylitis.
“We remain confident in the strong efficacy data and safety profile for RINVOQ, and we will continue to work closely with the FDA to bring the drug to patients living with the burden of atopic dermatitis and other immune-mediated diseases,” said Michael Severino, MD, Vice Chairman and Chairman, AbbVie.
About RINVOQ® (upadacitinib)
Discovered and developed by scientists at AbbVie, RINVOQ is a selective and reversible JAK inhibitor under investigation in several immune-mediated inflammatory diseases. In August 2019RINVOQ received approval from the US FDA for adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to or were intolerant to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response to or are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have had an inadequate response to conventional therapy. The approved dose for RINVOQ in these indications is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis are underway.
Important Safety Information About RINVOQ (upadacitinib)
RINVOQ US Usage and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or was not tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.
What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that may reduce your immune system’s ability to fight infection. You should not start taking RINVOQ if you have an infection unless your healthcare provider (HCP) tells you it is okay.
- Serious infections have occurred in some people 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 professional should test you for TB before starting RINVOQ and monitor you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
- Lymphoma and other cancers, including skin cancer, can occur in people taking RINVOQ.
- Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This can be life-threatening and cause death.
- Tears in the stomach or intestines and changes in certain lab tests may occur. Your healthcare professional should do blood tests before you start taking RINVOQ and while you are taking it. Your healthcare professional may stop your treatment with RINVOQ for a period of time if necessary because of changes in these blood test results.
What should I tell my HCP BEFORE I start RINVOQ?
Tell your healthcare provider if you:
- Are being treated for an infection, have an infection that doesn’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 strain
- Feeling tired
- Blood in mucus
- Diarrhea or stomach pain
- weight loss
- Burning when urinating or urinating more often than usual
- Have or have been in close contact with someone with TB.
- You have had cancer, hepatitis B or C, shingles (herpes zoster) or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the colon), 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 that increase your risk of getting certain types of fungal infections, such as the Ohio and Mississippi Valleys and the Southwest. If you are not sure if you have been to these areas, ask your HCP.
- Have recently received a vaccine or are scheduled to be vaccinated. People taking RINVOQ should not receive live vaccines.
- Are you pregnant or planning to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your healthcare professional will check whether or not you are pregnant before starting RINVOQ. You must use effective birth control (birth control) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
- Are you breast-feeding or planning to breast-feed? RINVOQ can pass into your breast milk. You should not breast-feed while taking RINVOQ and for at least 6 days after your last dose.
Tell your HCP about all medications you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements. RINVOQ and other medicines can affect each other and cause side effects.
In particular, tell your healthcare professional if you:
- Medicines for fungal or bacterial infections
- Rifampicin or Phenytoin
- Drugs That Affect Your Immune System
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist for advice.
What should I tell my HCP AFTER starting RINVOQ?
Tell your healthcare provider right away if you:
- Having symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
- You have signs or symptoms of blood clots during treatment with RINVOQ, including:
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- shortness of breath
- Having a fever or pain in the stomach area that won’t go away, and a change in your bowel habits.
What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (cold, sinusitis), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.
RINVOQ is taken once daily with or without food. Do not split, break, crush or chew the tablet. Use RINVOQ exactly as your doctor tells you to use it.
This is the most important information about RINVOQ. Please contact your HCP for more information. You are encouraged to report adverse side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you’re having trouble paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist learn more.
AbbVie’s mission is to discover and deliver innovative medicines that solve today’s serious health problems and tomorrow’s medical challenges. We strive to make a remarkable impact on people’s lives in several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services in its Allergan Aesthetics- portfolio. For more information about AbbVie, visit us at: www.abbvie.com. Follow @abbvie on Twitter, facebook, LinkedIn or Instagram.
Certain statements in this press 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, among others, identify generally forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the anticipated benefits of the acquisition of Allergan plc (“Allergan”) by AbbVie, failure to integrate Allergan’s business in a timely and effective manner, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse lawsuits or government action, changes in laws and regulations applicable to our industry, and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that could affect AbbVie’s business is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2020 Annual Report on Form 10-K, filed with the Securities and Exchange Commission, as updated by subsequent quarterly reports on Form 10-Q. AbbVie assumes no obligation to publicly disclose any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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