NORTH CHICAGO, Ill.,
Aug. 16, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) has approved RINVOQ™
(upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK)
inhibitor, for the treatment of adults with moderately to severely
active rheumatoid arthritis (RA) who have had an inadequate
response or intolerance to methotrexate
(MTX-IR).1 RINVOQ is expected to be available in
the U.S. in late August 2019.
The FDA approval of RINVOQ is supported by data from the SELECT
program, one of the largest registrational Phase 3 programs in RA
with approximately 4,400 patients evaluated across all treatment
arms in five studies.2-6 The studies
include assessments of efficacy, safety and tolerability across a
variety of RA patients, including those who failed or were
intolerant to biologic disease-modifying anti-rheumatic drugs and
who were naïve or inadequate responders to methotrexate. RINVOQ is
not indicated for methotrexate-naïve patients.
"Despite the availability of multiple treatment options with
varying mechanisms of action, many patients still do not achieve
clinical remission or low disease activity—the primary treatment
goals for rheumatoid arthritis," said Roy
M. Fleischmann, M.D., primary investigator for
SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at
Dallas. "With this FDA approval, RINVOQ has the potential to
help additional people living with RA achieve remission who have
not yet reached this goal."
Across the SELECT Phase 3 studies, RINVOQ met all primary
and ranked secondary endpoints. The primary endpoints include:
- In SELECT-EARLY, 52 percent of MTX-naïve patients treated with
RINVOQ 15 mg achieved ACR50 vs 28 percent treated with MTX at week
121
- In SELECT-MONOTHERAPY, 68 percent of MTX-IR patients treated
with RINVOQ 15 mg achieved ACR20 vs 41 percent treated with
continued MTX at week 141
- In SELECT-COMPARE, 71 percent of MTX-IR patients treated with
RINVOQ 15 mg plus MTX achieved ACR20 vs 36 percent treated with
placebo plus MTX at week 121
- In SELECT-NEXT, 64 percent of csDMARD-IR patients treated with
RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 36 percent treated
with placebo plus csDMARDs at week 121
- In SELECT-BEYOND, 65 percent of biologic-IR patients treated
with RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 28 percent
treated with placebo plus csDMARDs at week 121
"The discovery and development of RINVOQ is indicative of
AbbVie's long-standing commitment to advancing the science for
people living with immune-mediated conditions," said Michael Severino, M.D., vice chairman and
president, AbbVie. "Today's FDA approval marks an important
milestone in our pursuit to deliver innovative medicines that
advance care for people living with rheumatoid arthritis."
Clinical Remission
Patients taking RINVOQ achieved
clinical remission, a state characterized by almost no disease
activity and symptoms, even without
methotrexate.2-3,6 Approximately
30 percent of patients treated with RINVOQ achieved clinical
remission (as assessed by DAS28-CRP<2.6) at week 12 in
SELECT-COMPARE and week 14 in SELECT-MONOTHERAPY compared to six
percent with placebo plus methotrexate and eight percent with
methotrexate, respectively.1 In SELECT-EARLY, 36
percent of patients treated with RINVOQ achieved clinical remission
(as assessed by DAS28-CRP<2.6) at week 12 compared to 14 percent
with methotrexate.1
Durable remission rates were observed up to week 26. Forty-eight
percent of patients treated with RINVOQ alone in SELECT-EARLY and
41 percent of patients treated with RINVOQ plus methotrexate in
SELECT-COMPARE achieved clinical remission at weeks 24 and 26,
compared to nine percent with placebo plus methotrexate and 18
percent with methotrexate, respectively.1 Analysis at
weeks 24 and 26 were not controlled for multiple
comparisons.3,10
Radiographic Inhibition
RINVOQ significantly inhibited
radiographic progression as measured by the change in modified
total Sharp score (mTSS) from baseline compared to methotrexate in
SELECT-EARLY (0.14 vs 0.67) and RINVOQ plus methotrexate compared
to placebo plus methotrexate in SELECT-COMPARE (0.15 vs 0.78)
through weeks 24 and 26,
respectively.1
Safety
The most common side effects associated with
RINVOQ include upper respiratory tract infections (common cold,
sinus infections), nausea, cough and
pyrexia.1 Patients treated with RINVOQ are at
increased risk for developing serious infections that may lead to
hospitalization or death. These infections include tuberculosis
(TB), invasive fungal, bacterial, viral, and other infections due
to opportunistic pathogens. Most patients who developed these
infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids.1 Lymphoma and
other malignancies have been observed in RINVOQ-treated
patients.1 Thrombosis, including deep
vein thrombosis, pulmonary embolism, and arterial thrombosis, have
occurred in patients treated with JAK inhibitors used to treat
inflammatory conditions.1 Patients treated with
RINVOQ also may be at risk for other serious adverse reactions,
including gastrointestinal perforations, neutropenia, lymphopenia,
anemia, lipid elevations, liver enzyme elevations, and embryo-fetal
toxicity.1
Ease of Use and Access
Designed to help accommodate
the physical limitations of people living with RA, the packaging
for RINVOQ includes a bottle cap with a wide, easy-to-grip texture
and an embedded tool that punctures the foil liner to simplify
medication access. This packaging design was awarded the Arthritis
Foundation Ease of Use Commendation.
"Rheumatoid arthritis can have a debilitating impact on the
lives of those with the chronic disease, including making it
difficult to perform everyday tasks," said Cindy McDaniel, senior vice president, consumer
health, Arthritis Foundation. "The Arthritis Foundation is
committed to recognizing innovation that can help patients living
with rheumatoid arthritis and we are proud to recognize AbbVie with
our Ease of Use Commendation for the packaging design of
RINVOQ."
AbbVie continues to work closely with key stakeholders to
support patient access to RINVOQ, including offering a patient
support program and a co-pay card that may reduce out-of-pocket
costs to $5 per month for eligible,
commercially-insured patients. For those with limited or no health
insurance, AbbVie offers myAbbVie Assist, a patient assistance
program that provides RINVOQ to qualifying patients.
About Rheumatoid Arthritis
Affecting 1.3 million
Americans, rheumatoid arthritis is a complex, systemic autoimmune
disease that occurs when the immune system mistakenly attacks
joints, creating inflammation that causes the tissue inside of
joints to thicken, damaging the bones and associated connective
tissue.11-12 Pain, fatigue and stiffness are among the
signs and symptoms of RA that can have an impact on daily
living.13 If not properly treated, RA can lead to
permanent, debilitating bone and cartilage damage.
The full U.S. prescribing information, including Medication
Guide, for RINVOQ can be found on rxabbvie.com.
About RINVOQ1
RINVOQ is an oral,
small molecule JAK inhibitor being studied for moderately to
severely active rheumatoid arthritis and other immune-mediated
diseases. RINVOQ is under review by the European Medicines
Agency (EMA), as well as regulatory authorities in Canada and Japan, for the treatment of adult patients
with moderately to severely active RA.
RINVOQ U.S. Use and Important Safety
Information1
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.
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than 75
countries, AbbVie employees are working every day to advance health
solutions for people around the world. For more information about
AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
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, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. 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 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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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Rheumatoid Arthritis. Available at:
https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php.
Accessed on July 9, 2019
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Accessed on June 7, 2019.
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