NORTH CHICAGO, Ill.,
Oct. 19, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that it has submitted
applications to the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) seeking approval for RINVOQ™
(upadacitinib) for the treatment of adults (15 mg and 30 mg, once
daily) and adolescents (15 mg, once daily) with moderate to severe
atopic dermatitis.
The atopic dermatitis indication applications to the FDA and EMA
are supported by data from three pivotal Phase 3 studies. RINVOQ
was studied without topical corticosteroids (TCS) in Measure
Up 1 and Measure Up 2 and with TCS in AD Up.1-3 In all
three studies, RINVOQ demonstrated significant improvement in skin
clearance and reduction in itch in adults and adolescents
with moderate to severe atopic dermatitis compared to
placebo.1-3 RINVOQ met the co-primary endpoints
including at least a 75 percent improvement in the Eczema Area
Severity Index (EASI 75) from baseline and a validated
Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
score of 0/1 (clear or almost clear) at week 16.1-3
Additionally, more patients treated with either dose of
upadacitinib experienced a clinically meaningful reduction in itch,
defined as improvement in Worst Pruritus Numerical Rating Scale
(NRS)≥4.1-3 The safety profile of RINVOQ was consistent
across the three pivotal Phase 3 studies in atopic
dermatitis.1-3 No new safety risks of RINVOQ were
observed in these studies compared to the safety profile observed
in patients with rheumatoid arthritis, psoriatic arthritis or
ankylosing spondylitis receiving RINVOQ.1-3,8-11
"While there have been advancements in care, patients with
moderate to severe atopic dermatitis continue to experience
relentless itch and skin symptoms that can impact their everyday
lives," said Michael Severino, M.D.,
vice chairman and president, AbbVie. "These submissions are an
important step forward in our commitment to providing an additional
treatment option for those who struggle with this debilitating and
often underappreciated disease."
Atopic dermatitis is characterized by a cycle of itching and
scratching that leads to cracked, scaly, oozing skin, which
intensifies with worsening disease severity.4,5,12
Between 20 to 46 percent of adults with atopic dermatitis have
moderate to severe disease.13 The range of symptoms pose
significant physical, psychological and economic burden on
individuals impacted by the disease.4-6
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.1-3,14-22
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 atopic dermatitis, psoriatic arthritis,
rheumatoid arthritis, axial spondyloarthritis, Crohn's disease,
ulcerative colitis, giant cell arteritis and Takayasu arteritis are
ongoing.14-22 Use of RINVOQ in atopic dermatitis is not
approved and its safety and efficacy have not been established by
regulatory authorities.
Important Safety Information about RINVOQ™
(upadacitinib)23
RINVOQ U.S. Use 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 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
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:
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- AbbVie Data on File. ABVRRTI70838.
- AbbVie Data on File. ABVRRTI70869.
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