NORTH CHICAGO, Ill.,
May 26, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced data from its migraine portfolio will
be presented at the 2021 American Headache Society (AHS) Annual
Scientific Meeting, to be held virtually June 3-6. A total of 23 abstracts, including four
podium presentations, will be shared from a broad range of studies
across AbbVie's migraine portfolio.
"Migraine is an often-debilitating disease that affects millions
of people in the prime of their lives, which is why the significant
advancements AbbVie has made in the development of preventive and
acute treatment options are so important," said Mitchell Mathis, M.D., vice president,
neuroscience, AbbVie. "The data AbbVie is presenting at AHS span
our full migraine portfolio and is a result of our ongoing
commitment to drive progress for the migraine community."
Researchers will present data from several migraine studies,
including findings on atogepant, AbbVie's investigational
preventive treatment of migraine in adults who meet criteria for
episodic migraine, as well as data on UBRELVY®
(ubrogepant) and BOTOX® (onabotulinumtoxinA).
Key AbbVie abstracts and presentation details for the 2021 AHS
Annual Scientific Meeting are outlined below.
Abstract
Title
|
Presentation
Details
|
Characterizing
Preventive Treatment Gaps in Migraine: Results from the CaMEO
Study
|
Podium
presentation
on demand
|
Atogepant
Significantly Reduces Mean Monthly Migraine Days in the Phase 3
Trial (ADVANCE) for the Prevention of Migraine
|
Podium
presentation
on demand
|
Combining UbRogepAnt
and Preventives for MiGrainE (COURAGE) Study Using the Migraine
Buddy Application: A Novel, Entirely Remote Design for Collecting
Real-world Evidence
|
Podium
presentation
on demand
|
Real-World Evidence
for Control of Patients with Chronic Migraine Who Received
Calcitonin Gene‒Related Peptide Monoclonal Antibody Therapy Added
to OnabotulinumtoxinA
Treatment
|
Podium
presentation
on demand
|
Impact of Prior
Monthly Headache Days on Migraine-Related Quality of Life: Results
from the CaMEO Study
|
Live-streamed poster
presentation
Friday, June 4
11:50 a.m. – 12:00 p.m. ET
|
Optimal Acute
Treatment Is Associated with Productivity Gains in People with
Migraine: Results from the Chronic Migraine Epidemiology and
Outcomes (CaMEO) Study
|
Live-streamed poster
presentation
Friday, June
4
1:00 p.m. - 1:10 p.m.
ET
|
Real-World Evidence
for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy
Added to OnabotulinumtoxinA Treatment for Migraine Prevention in
Adult Patients with Chronic Migraine
|
[Late-Breaker]
Poster
|
Daily Atogepant for
the Preventive Treatment of Migraine Increases Responder Rates for
Reduction in Mean Monthly Migraine Days
|
Poster
|
Daily Atogepant
Provides a Rapid Onset and Sustained Benefit in the Preventive
Treatment of Migraine
|
Poster
|
Atogepant 60 mg
Once-Daily Shows Efficacy for the Preventive Treatment of Migraine:
Results From a 52-Week Open-Label Extension Trial
|
Poster
|
Daily Dosing of
Atogepant for the Preventive Treatment of Migraine Improved
Patient-reported Outcome Measures of Activity Impairment
Migraine-Diary, Migraine-Specific Quality of Life, and Headache
Impact in a 52-week Trial
|
Poster
|
Ubrogepant Treatment
When Pain is Mild Increases the Likelihood of Achieving Pain
Freedom in Participants Who Treated Migraine Attacks of Mild and
Moderate or Severe Pain
|
Poster
|
A Novel Approach to
Defining Success in the Acute Treatment of Migraine: Demonstrating
Therapeutic Benefit at 1 Hour Post-dose in the Pooled ACHIEVE I and
ACHIEVE II Trials
|
Poster
|
The 2021 AHS Annual Scientific Session agenda can be found
here.
About Atogepant
Atogepant is an investigational orally administered, CGRP receptor
antagonist (gepant) specifically developed for the preventive
treatment of migraine. CGRP and its receptors are expressed in
regions of the nervous system associated with migraine
pathophysiology. Studies have shown that CGRP levels are elevated
during migraine attacks and selective CGRP receptor antagonists
confer clinical benefit in migraine. Atogepant is currently under
review by the U.S. Food and Drug Administration. AbbVie anticipates
a regulatory decision in late Q3 2021.
About BOTOX®
BOTOX® was
first approved by the FDA in 1989 for two rare eye muscle disorders
– blepharospasm and strabismus in adults. Today, BOTOX®
is FDA-approved for 12 therapeutic indications, including Chronic
Migraine, overactive bladder, leakage of urine (incontinence) due
to overactive bladder caused by a neurologic condition in adults,
cervical dystonia, adult and pediatric spasticity, severe underarm
sweating (axillary hyperhidrosis), and pediatric detrusor
overactivity associated with a neurologic condition.
BOTOX® (onabotulinumtoxinA)
Important Information
Indications
BOTOX® is
a prescription medicine that is injected into muscles
and used:
- To treat overactive bladder symptoms such as a strong need to
urinate with leaking or wetting accidents (urge urinary
incontinence), a strong need to urinate right away (urgency), and
urinating often (frequency) in adults 18 years and older when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and
older with overactive bladder caused by a neurologic disease who
still have leakage or cannot tolerate the side effects after trying
an anticholinergic medication
- To treat overactive bladder due to a neurologic disease in
children 5 years of age and older when another type of medicine
(anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with chronic migraine who have
15 or more days each month with headache lasting 4 or more hours
each day in people 18 years or older
- To treat increased muscle stiffness in people 2 years of age
and older with spasticity
- To treat the abnormal head position and neck pain that happens
with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years of
age and older
BOTOX® is also injected into the skin to treat
the symptoms of severe underarm sweating (severe primary axillary
hyperhidrosis) when medicines used on the skin (topical) do not
work well enough in people 18 years and older.
It is not known whether
BOTOX® is safe and
effective to prevent headaches in
patients with migraine
who have 14 or fewer headache days
each month (episodic migraine).
BOTOX® has not been shown to help people perform
task-specific functions with their upper limbs or increase movement
in joints that are permanently fixed in position by stiff
muscles.
It is not known whether BOTOX® is
safe and effective for severe sweating anywhere other
than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects
that can be life threatening. Get medical help right away if you
have any of these problems any time (hours to weeks) after
injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, and trouble swallowing
There has not been a confirmed serious
case of spread of toxin effect away from
the injection site when BOTOX® has
been used at the recommended dose to
treat chronic migraine, severe
underarm sweating, blepharospasm, or strabismus.
BOTOX® may cause loss of strength or general muscle
weakness, vision problems, or dizziness within hours to weeks of
taking BOTOX®. If this happens, do
not drive a car, operate machinery, or do
other dangerous activities.
Do not
receive BOTOX® if you: are
allergic to any of the ingredients in BOTOX® (see
Medication Guide for ingredients); had an allergic reaction to any
other botulinum toxin product such as Myobloc®
(rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or
Xeomin® (incobotulinumtoxinA); have a skin infection at
the planned injection site.
Do not receive BOTOX® for
the treatment of urinary incontinence if
you: have a urinary tract infection (UTI)
or cannot empty your bladder on your
own and are not routinely catheterizing.
Due to the risk
of urinary retention (not being able to empty the bladder), only
patients who are
willing and able to initiate catheterization post treatment, if
required, should be considered for
treatment.
Patients treated for overactive bladder:
In clinical trials, 36 of the 552 patients had to self-catheterize
for urinary retention following treatment with BOTOX®
compared to 2 of the 542 treated with placebo. The median duration
of post-injection catheterization for these patients treated with
BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to
maximum 214 days) as compared to a median duration of 11 days
(minimum 3 days to maximum 18 days) for patients receiving placebo
(n = 2). Patients with diabetes mellitus treated with
BOTOX® were more likely to develop urinary retention
than nondiabetics.
Adult Patients treated for overactive bladder
due to neurologic disease:
In clinical trials, 30.6% of patients (33/108) who were not using
clean intermittent catheterization (CIC) prior to injection,
required catheterization for urinary retention following treatment
with BOTOX® 200 Units as compared to 6.7% of patients
(7/104) treated with placebo. The median duration of post-injection
catheterization for these patients treated with BOTOX®
200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days)
as compared to a median duration of 358 days (minimum 2 days to
maximum 379 days) for patients receiving placebo (n = 7). Among
patients not using CIC at baseline, those with MS were more likely
to require CIC post injection than those with SCI.
The dose of
BOTOX® is not
the same as, or comparable to, another
botulinum toxin product.
Serious and/or immediate
allergic reactions have been
reported, including itching, rash, red itchy welts,
wheezing, asthma symptoms, dizziness, or feeling faint. Get medical
help right away if you experience symptoms; further injection of
BOTOX® should be discontinued.
Tell your doctor about all your
muscle or nerve conditions, such as
ALS or Lou Gehrig's disease,
myasthenia gravis, or Lambert-Eaton syndrome, as you may be at
increased risk of serious side effects, including difficulty
swallowing and difficulty breathing from typical doses
of BOTOX®.
Tell your doctor if you have any
breathing-related problems. Your doctor may monitor you
for breathing problems during treatment with BOTOX® for
spasticity or for detrusor overactivity associated with a
neurologic condition. The risk of developing lung disease in
patients with reduced lung function is increased in patients
receiving BOTOX®.
Cornea problems have been
reported. Cornea (surface of the eye) problems have
been reported in some people receiving BOTOX® for their
blepharospasm, especially in people with certain nerve disorders.
BOTOX® may cause the eyelids to blink less, which could
lead to the surface of the eye being exposed to air more than is
usual. Tell your doctor if you experience any problems with your
eyes while receiving BOTOX®. Your doctor may treat your
eyes with drops, ointments, contact lenses, or with an eye
patch.
Bleeding behind the eye has been
reported. Bleeding behind the eyeball has been reported in
some people receiving BOTOX® for their strabismus. Tell
your doctor if you notice any new visual problems while receiving
BOTOX®.
Bronchitis and upper respiratory tract
infections (common colds) have been reported. Bronchitis was
reported more frequently in adults receiving BOTOX® for
upper limb spasticity. Upper respiratory infections were also
reported more frequently in adults with prior breathing-related
problems with spasticity. In pediatric patients treated with
BOTOX® for upper limb spasticity, upper respiratory
tract infections were reported more frequently. In pediatric
patients treated with BOTOX® for lower limb spasticity,
upper respiratory tract infections were not reported more
frequently than placebo.
Autonomic dysreflexia in patients treated for
overactive bladder due to neurologic disease.
Autonomic dysreflexia associated with intradetrusor injections of
BOTOX® could occur in patients treated for detrusor
overactivity associated with a neurologic condition and may require
prompt medical therapy. In clinical trials, the incidence of
autonomic dysreflexia was greater in adult patients treated with
BOTOX® 200 Units compared with placebo (1.5% versus
0.4%, respectively).
Tell your doctor about all your
medical conditions, including if you: have
or have had bleeding problems; have plans to have surgery; had
surgery on your face; weakness of forehead muscles; trouble raising
your eyebrows; drooping eyelids; any other abnormal facial change;
have symptoms of a urinary tract infection (UTI) and are being
treated for urinary incontinence (symptoms of a urinary tract
infection may include pain or burning with urination, frequent
urination, or fever); have problems emptying your bladder on your
own and are being treated for urinary incontinence; are pregnant or
plan to become pregnant (it is not known if BOTOX®
can harm your unborn baby); are breastfeeding or
plan to (it is
not known if BOTOX® passes into breast milk).
Tell your doctor
about all the medicines you
take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements. Using BOTOX® with
certain other medicines may cause
serious side effects. Do not start any new
medicines until you have told your doctor
that you have received
BOTOX® in the past.
Tell your doctor
if you received any other
botulinum toxin product in the last 4
months; have received injections of botulinum toxin such as
Myobloc®, Dysport®, or
Xeomin® in the past (tell your
doctor exactly
which product you received); have recently
received an antibiotic by injection; take muscle relaxants; take an
allergy or cold medicine; take a sleep medicine; take aspirin-like
products or blood thinners.
Other side effects
of BOTOX® include: dry mouth,
discomfort or pain at the injection site, tiredness, headache, neck
pain, eye problems: double vision, blurred vision, decreased
eyesight, drooping eyelids, swelling of your eyelids, dry eyes;
drooping eyebrows; and upper respiratory tract infection. In adults
being treated for urinary incontinence, other side effects include
urinary tract infection and painful urination. In children being
treated for urinary incontinence, other side effects include
urinary tract infection and bacteria in the urine. If you have
difficulty fully emptying your bladder on your own after receiving
BOTOX®, you may need to use disposable self-catheters to
empty your bladder up to a few times each day until your bladder is
able to start emptying again.
For more information refer
to the Medication Guide or talk with your
doctor.
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.
Please see BOTOX® full
Product Information, including Boxed Warning and
Medication Guide.
About UBRELVY® (ubrogepant)
UBRELVY® (ubrogepant) is an orally administered
calcitonin gene-related peptide (CGRP) receptor antagonist (gepant)
for the acute treatment of migraine with or without aura in adults
that is an option for a wide range of patients who experience
migraine attacks. UBRELVY® is the first pill of its kind
to directly block CGRP, a protein released during a migraine
attack, from binding to its receptors.
IMPORTANT SAFETY INFORMATION
Who should not take UBRELVY® (ubrogepant)?
Do not take UBRELVY® if you are taking medicines known
as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin,
itraconazole.
What should I tell my healthcare provider before taking
UBRELVY®?
Tell your healthcare provider about all your medical conditions,
including if you:
- Have liver problems
- Have kidney problems
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Your healthcare
provider can tell you if it is safe to take UBRELVY®
with other medicines.
What are the most common side effects of
UBRELVY®?
The most common side effects are nausea (4%) and sleepiness (3%).
These are not all of the possible side effects of
UBRELVY®.
What is UBRELVY® (ubrogepant)?
UBRELVY® is a prescription medicine used for the acute
treatment of migraine attacks with or without aura in adults.
UBRELVY® is not used to prevent migraine headaches.
Please see full Prescribing Information.
About AbbVie Leadership in Migraine
AbbVie, a leader in the migraine space, markets
BOTOX® (onabotulinumtoxinA), the first
FDA-approved, preventive treatment for adults with Chronic Migraine
and UBRELVY® (ubrogepant), the first FDA-approved
oral calcitonin gene-related peptide (CGRP) receptor antagonist
(gepant), which is indicated for the acute treatment of migraine
with or without aura in adults.
About AbbVie in Neuroscience
At AbbVie, our commitment
to preserve the personhood of those living with neurological and
psychiatric disorders is unwavering. Every challenge in this
uncharted territory makes us more determined and drives us harder
to discover and deliver solutions for patients, care partners and
clinicians. AbbVie's Neuroscience portfolio consists of approved
therapies and a robust pipeline in neurological and psychiatric
disorders, including Alzheimer's disease, bipolar I disorder,
major depressive disorder, migraine, Parkinson's
disease, spinal cord injuries, post-stroke spasticity,
schizophrenia, stroke and others.
We have a strong investment in neuroscience research, with our
Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery
site in Ludwigshafen, Germany, where our research and
resilience in these challenging therapeutic areas is yielding a
deeper understanding of the pathophysiology of neurological and
psychiatric disorders, and identifying targets for potential
disease-modifying therapeutics aimed at making a difference in
people's lives.
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 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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