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™ (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™ (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™
(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.
References:
- Van der Heijde D, et al. Efficacy and Safety of Upadacitinib in
a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase
2/3 Clinical Study of Patients With Active Ankylosing Spondylitis.
2019 ACR/ARP; 2728.
- Cohen S, et al. Safety profile of upadacitinib in Rheumatoid
Arthritis: Integrated analysis from the SELECT Phase 3 Clinical
Program. EULAR 2019; THU0167.
- McInnes I, et al. Efficacy and Safety of Upadacitinib Versus
Placebo and Adalimumab in Patients With Active Psoriatic Arthritis
and Inadequate Response to Non-Biologic Disease-Modifying
Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized
Controlled Phase 3 Trial. 2020 EULAR E-Congress; LB0001.
- Guttman-Yassky, E et al. ePoster #P0236. 27th European Academy
of Dermatology and Venerology (EADV) Congress. September 2018.
- Dean, LE, et al. Global prevalence of ankylosing spondylitis.
Rheumatology (Oxford). 2014 Apr;53(4):650-7. doi:
10.1093/rheumatology/ket387. Epub 2013 Dec
9.
- Sieper J, et al. Ankylosing spondylitis: an overview. Ann Rheum
Dis. 2002 Nov; 61(Suppl 3): iii8–iii18. doi:
10.1136/ard.61.suppl_3.iii8.
- Ozgul, A., et al. Effect of ankylosing spondylitis on
health-related quality of life and different aspects of social life
in young patients. Clin Rheumatol. 2006 Mar;25(2):168-74. Epub 2005
Aug 10.
- Martindale, J., et al. Disease and psychological status in
ankylosing spondylitis. Rheumatology (Oxford). 2006
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- Boonen, A., et al. The burden of ankylosing spondylitis. J
Rheumatol Suppl. 2006 Sep;78:4-11.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed
on August 17, 2020.
- Burmester G.R., et al. Safety and efficacy of upadacitinib in
patients with rheumatoid arthritis and inadequate response to
conventional synthetic disease-modifying anti-rheumatic drugs
(SELECT-NEXT): a randomised, double-blind, placebo-controlled phase
3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
Disease Who Have Inadequately Responded to or Are Intolerant to
Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02365649.
Accessed on August 17, 2020
- A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed on August 17, 2020.
- A Study Evaluating the Safety and Efficacy of Upadacitinib in
Subjects With Active Ankylosing Spondylitis (SELECT Axis 1).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/study/NCT03178487.
Accessed on August 17, 2020.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed
on August 17, 2020.
- A Study to Evaluate Upadacitinib in Adolescent and Adult
Subjects With Moderate to Severe Atopic Dermatitis.
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03607422.
Accessed on August 17, 2020.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to
Adalimumab in Participants With Psoriatic Arthritis Who Have an
Inadequate Response to at Least One Non-Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2020.
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- RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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