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 supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.
AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.
Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.
"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," said Michael Severino, M.D., vice chairman and president, AbbVie.
About Upadacitinib (RINVOQ)
Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2. In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have 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)
RINVOQ U.S. Use and Important Safety InformationRINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be 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 can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.
-- Serious infections have happened 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 HCP should test you for TB before starting RINVOQ and check 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 cancers, can happen in people taking RINVOQ.
-- Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
-- Tears in the stomach or intestines and changes in certain laboratory tests can happen. 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.
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
-- Weight loss
-- Burning when urinating or urinating more often than normal
-- Have TB or have been in close contact with someone with TB.
-- Have had any type of 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 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 that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these 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 while taking RINVOQ and for at least 4 weeks after your last dose.
-- Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 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
Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.
What should I 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.
-- Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
-- Sudden unexplained chest pain
-- Pain or tenderness in the leg
-- Shortness of breath
-- Have a fever or stomach-area pain that does not 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 the possible side effects of RINVOQ.
RINVOQ is taken once a day 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 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 http://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/myAbbVieAssist 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 AbbVieAbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com/. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking StatementsSome 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, among others, 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 indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to 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 may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 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 to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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