NORTH CHICAGO, Ill., March 17, 2021 / PRNewswire / – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug supplemental order (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated action date of the Prescription Drug User Fee Act (PDUFA) has been extended by three months until the end of the second quarter of 2021.
AbbVie recently received a request for information from the FDA for an updated assessment of the risk-benefit profile of upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require more time for a complete review of the submission.
Separately, AbbVie received a similar request from the FDA related to sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.
“We remain confident in sNDA and committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases,” said Michael Severino, MD, vice president and president of AbbVie.
About Upadacitinibe (RINVOQ)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible oral JAK inhibitor, once daily, studied in several immune-mediated inflammatory diseases. It was designed to have greater inhibitory power for JAK1 versus JAK2, JAK3 and TYK2. In August 2019, RINVOQ received approval from the U.S. Food and Drug Administration for adult patients with moderate to severe active rheumatoid arthritis who had an inadequate response or intolerance to methotrexate. RINVOQ has also been approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who responded inadequately or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis and giant cell arteritis are ongoing.
Important safety information about RINVOQ (upadacitinib)
Important safety and usage information for RINVOQ US
RINVOQ is a prescription medication used to treat adults with moderate to severe rheumatoid arthritis, in which methotrexate has not worked well or could not be tolerated. It is not known whether 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 can decrease your immune system’s ability to fight infections. You should not start taking RINVOQ if you have any type of infection, unless your doctor (HCP) says everything is fine.
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Serious infections have occurred in some people who have taken RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi or viruses that can spread throughout the body. Some people died from these infections. Your HCP should test you for TB before starting RINVOQ and carefully examine you for signs and symptoms of TB during treatment with RINVOQ. You may be at a higher risk of developing shingles.
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Lymphoma and other cancers, including skin cancer, can occur in people who take RINVOQ.
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Blood clots in the veins in the legs or lungs and arteries are possible in some people who take RINVOQ. This can be fatal and cause death.
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Tears in the stomach or intestines and changes in certain laboratory tests may occur. Your HCP should have blood tests before you start taking RINVOQ and while you are taking it. Your HCP may interrupt treatment with RINVOQ for a period of time, if necessary, due to changes in blood test results.
What should I tell my HCP BEFORE starting RINVOQ?
Inform your HCP if you:
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They are being treated for an infection, have an infection that does not pass or keeps coming back, or have symptoms of an infection, such as:
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You have tuberculosis or have been in close contact with someone with tuberculosis.
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Had any type of cancer, hepatitis B or C, herpes zoster or blood clots in the veins of the legs or lungs, diverticulitis (inflammation in parts of the large intestine) or ulcers in the stomach or intestines.
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You have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV or a weak immune system.
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Live, have lived or traveled to parts of the country that increase the risk of contracting certain types of fungal infections, such as the Ohio and Mississippi River valleys and the southwest. If you are not sure if you have been to these areas, ask your HCP.
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You have recently received or are scheduled to receive a vaccine. People taking RINVOQ should not receive live vaccines.
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You are pregnant or plan to become pregnant. Based on animal studies, RINVOQ can harm your unborn baby. Your HCP will check whether you are pregnant or not before starting RINVOQ. You must use an effective method of contraception (contraception) to avoid becoming pregnant while taking RINVOQ and at least 4 weeks after your last dose.
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Are breastfeeding or plan to breastfeed. RINVOQ can pass into breast milk. You should not breast-feed while taking RINVOQ and at least 6 days after your last dose.
Tell your HCP about all medications you take, including prescription and over-the-counter medications, vitamins and herbal supplements. RINVOQ and other medications can affect each other, causing side effects.
In particular, tell your HCP if you take:
Ask your healthcare professional or pharmacist if you are unsure whether you are taking any of these medicines.
What should I tell my HCP AFTER starting RINVOQ?
Inform your HCP immediately if you:
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Has some symptom of infection. RINVOQ can increase the likelihood that you will get infections or make any infection worse.
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You have any signs or symptoms of blood clots during treatment with RINVOQ, including:
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You have a fever or pain in your stomach that doesn’t go away and a change in your bowel habits.
What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough and fever. These are not all possible side effects of RINVOQ.
RINVOQ is administered once daily with or without food. Do not split, break, crush or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.
This is the most important information you should know about RINVOQ. For more information, speak to your HCP. We recommend that you report the negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having trouble paying for your medicine, AbbVie can help you. Visit AbbVie.com/myAbbVieAssist learn more.
Click here for the Complete Prescription and Drug Information Guide.
Overall, prescribing information varies; consult the product label for each country for complete information.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health problems today and address the medical challenges of tomorrow. We strive to have a notable impact on people’s lives in several important therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, as well as products and services across the Allergan Aesthetics portfolio. For more information about AbbVie, visit us at www.abbvie.com/. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some 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”, “wait”, “anticipate”, “project” and similar expressions, among others, they generally identify forward-looking statements. AbbVie warns that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s business, competition from other products, challenges to ownership intellectual, difficulties inherent in the research and development process, adverse litigation or government action, changes in laws and regulations applicable to our sector and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information on the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set out in Item 1A, “Risk Factors”, of AbbVie’s 2020 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission, as updated by their subsequent Quarterly Reports on Form 10-Q. AbbVie assumes no obligation to publicly disclose any revisions to the forward-looking statements as a result of subsequent events or developments, except as required by law.
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SOURCE AbbVie