AbbVie Submits Regulatory Application to FDA for RINVOQ(TM) (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis
NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ(TM) (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the European Medicines Agency (EMA) for RINVOQ earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
"Ankylosing spondylitis is a debilitating disease that can cause severe pain, restricted mobility and lasting structural damage. With limited treatment options, innovation is crucial to help more patients living with active ankylosing spondylitis reach their treatment goals," said Michael Severino, M.D., vice chairman and president, AbbVie. "RINVOQ has the potential to improve care by helping to provide disease control, addressing pain and improving function. We look forward to working with regulatory authorities and hope to bring this important treatment option to patients."
The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.(1) In this study, twice as many patients receiving RINVOQ (52 percent) met the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response versus placebo (26 percent) at week 14 (p<0.001).(1) The safety profile of RINVOQ in ankylosing spondylitis was consistent with previously reported studies across therapeutic areas, including rheumatoid arthritis, atopic dermatitis and psoriatic arthritis, with no new significant safety risks detected.(2-4)
Ankylosing spondylitis is a chronic, progressive, inflammatory musculoskeletal disease impacting more than five million people worldwide.(5,6 )The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.(5,)(7-9)
About RINVOQ(TM) (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.(10-17 )In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was 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. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.(12-17 )Use of RINVOQ in ankylosing spondylitis is not approved and its safety and efficacy have not been established by regulatory authorities.
Important Safety Information about RINVOQ(TM) (upadacitinib)(18)
RINVOQ 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
-- Cough
-- 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:
-- Swelling
-- Pain or tenderness in the leg
-- Sudden unexplained chest pain
-- 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 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 AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.
About AbbVie
AbbVie'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 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, 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 2019 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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