-- Fifteen abstracts underscore AbbVie's commitment to people
living with migraine
-- AbbVie to present late-breaking
data from the Chronic Migraine Epidemiology and Outcomes –
International (CaMEO-I) study on neck pain with headache in people
with and without migraine
-- Results from the PROGRESS
Phase 3 trial on atogepant for the preventive treatment of chronic
migraine in Europe will also be
presented
NORTH
CHICAGO, Ill., Dec. 6, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that data from
its robust migraine portfolio will be presented at the
16th European Headache Federation Congress 2022 (EHC
2022) taking place in Vienna,
Austria, December 7-10. A
total of 15 abstracts will cover a wide range of studies across
AbbVie's migraine portfolio, including data on onabotulinumtoxinA
and atogepant.
"AbbVie is a committed leader in migraine with extensive history
of migraine research. We work alongside patients, care partners and
clinicians to provide solutions for the often-unrelenting burden of
migraine," said Mudra Kapoor, M.D., vice president,
neuroscience, global medical affairs, AbbVie. "Our research
presented at this year's EHC 2022 reinforces our commitment to
making an impact in the migraine community and builds upon our
mission to provide therapies for people living with migraine."
At the meeting, researchers will present late-breaking data from
the Chronic Migraine Epidemiology and Outcomes - International
(CaMEO-I) study, evaluating the frequency and burden of neck pain
with headache among people with and without migraine.
AbbVie will also present the Phase 3 PROGRESS trial, including
results from patients with chronic migraine living in Europe. In addition to the data presented,
AbbVie will host a Medical Symposium on Friday, December 9 from 2:15-3:15 p.m. Central European Time (CET) titled
"A Paradigm Shift in Migraine Management."
AbbVie abstracts presented at the EHC 2022 are outlined
below.
Key AbbVie Abstracts
at EHC 2022
|
Abstract
Title
|
Abstract Details
& Time Zone:
Central European Time (CET)
|
Atogepant
|
Atogepant for the
Preventive Treatment of Chronic Migraine in Europe:
Results from the PROGRESS Study
|
Friday, December
9
16:15 – 16:20 pm
CET
ePoster
|
Atogepant for the
Preventive Treatment of Chronic Migraine: Results from
the PROGRESS Phase 3 Trial
|
Friday, December
9
15:30 – 15:35 pm
CET
ePoster
|
Sustained Response to
Atogepant in Individuals with Episodic Migraine: Post
Hoc Analyses of 12- and 52-Week Phase 3 Trials
|
Friday, December
9
15:40 – 15:45 pm
CET
ePoster
|
Monthly Migraine Days,
Acute Medication Use Days, and Migraine-Specific
Quality of Life in Responders to Atogepant: A Post Hoc
Analysis
|
Friday, December
9
16:55 – 17:00 pm
CET
ePoster
|
Subsequent Response to
Atogepant in Individuals with Episodic Migraine
after an Initial Inadequate Response: Post Hoc Analysis of a
12-week
Phase 3 Trial
|
Friday, December
9
16:05 – 16:10 pm
CET
ePoster
|
Post-hoc Analysis
Evaluating Safety of Atogepant in ADVANCE & Open-Label
Extension Participants with Cardiovascular Risk Factors
|
Friday, December
9
15:45 – 15:50 pm
CET
ePoster
|
Effect of Atogepant on
the Activity Impairment in Migraine–Diary and
Work Productivity and Activity Impairment Questionnaire in a
12-Week,
Double-blind, Randomized, Phase 3 (PROGRESS) Trial for
Preventive
Treatment of Chronic Migraine
|
Friday, December
9
16:05 – 16:10 pm
CET
ePoster
|
Treatment Responder
Rates of Oral Atogepant for the Preventive
Treatment of Chronic Migraine: Results from the PROGRESS
Trial
|
Friday, December
9
16:40 – 16:45 pm
CET
ePoster
|
Effect of Atogepant on
Migraine-Specific Quality of Life Questionnaire and
Headache Impact Test-6 in a 12-week, Double-blind, Randomized,
Phase 3 (PROGRESS) Trial for Preventive Treatment of Chronic
Migraine (CM)
|
Friday, December
9
16:00 – 16:05 pm
CET
ePoster
|
Safety and Tolerability
of Atogepant: A Post Hoc Analysis of
Pooled Data from Four Clinical Trials
|
Friday, December
9
15:55 – 16:00 pm
CET
ePoster
|
Migraine
Disease
|
|
Characterizing Neck
Pain with Headache in People with and without Migraine:
Results from the Chronic Migraine Epidemiology and Outcomes –
International
(CaMEO-I) Study
|
Friday, December
9
15:35 – 15:40 pm
CET
Late-Breaker
ePoster
|
Characterizing Gaps in
Preventive Treatment of Migraine: Global Results from
the CaMEO-International Study
|
Friday, December
9
15:50 – 15:55 pm
CET
ePoster
|
Chronic Migraine
Epidemiology and Outcomes – International (CaMEO-I) Study:
Methods and Global Findings for Diagnosis Rates and Care
|
Friday, December
9
16:45 – 16:50 pm
CET
ePoster
|
OnabotulinumtoxinA
|
|
Evaluation of PREEMPT
Fixed-dose, Fixed-site and Follow the Pain
Treatment Paradigms in the PREDICT Study
|
Friday, December
9
15:30 – 15:35 pm
CET
ePoster
|
Real-World Persistence
and Costs Among Patients with Chronic Migraine
Treated with OnabotulinumtoxinA or CGRP mAbs: A Retrospective
Claims
Analysis Study
|
Friday, December
9
16:25 – 16:30 pm
CET
ePoster
|
The EHC 2022 will be a hybrid meeting taking place in-person and
virtually. The full program for the congress can be found here.
About Atogepant
Atogepant is an 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. AbbVie has submitted a
marketing authorization application to the European Medicines
Agency for atogepant for the prophylaxis of migraine in adult
patients who have at least four migraine days per month. The use of
atogepant in migraine is not approved in the United Kingdom or European Union and its
safety and efficacy have not been evaluated.
U.S. Indications and Important Safety Information about
QULIPTA™ (atogepant)
QULIPTA is a prescription medicine used for the preventive
treatment of episodic migraine in adults.
IMPORTANT SAFETY INFORMATION
Before taking QULIPTATM (atogepant) tablets, tell
your healthcare provider about all your medical conditions,
including if you:
- Have kidney problems or are on dialysis
- Have liver problems
- Are pregnant or plan to become pregnant. It is not known if
QULIPTA will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if
QULIPTA passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby while taking
QULIPTA
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. QULIPTA may affect the way other
medicines work, and other medicines may affect how QULIPTA works.
Your healthcare provider may need to change the dose of QULIPTA
when taken with certain other medicines.
The most common side effects of QULIPTA are nausea,
constipation, and tiredness. These are not all the possible side
effects of QULIPTA.
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 see full Prescribing Information.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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
and in pediatric patients five years of age and older, cervical
dystonia, adult and pediatric spasticity, and severe underarm
sweating (axillary hyperhidrosis). Botulinum toxin units are not
interchangeable from one product to another; doses recommended in
Allergan Units are different from other botulinum toxin
preparations.
U.S. Indications and Important Safety Information about
BOTOX® (onabotulinumtoxinA)
INDICATIONS
BOTOX® (onabotulinumtoxinA) 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 due to a neurologic disease when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- 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 and 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
preexisting 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; 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 receiving
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 (difficulty
fully emptying the bladder), only patients who are willing and able
to initiate catheterization posttreatment, 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 postinjection
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 a
neurologic disease: In clinical trials, 30.6% of adult
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 postinjection 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 adult patients not using CIC at baseline, those with
multiple sclerosis were more likely to require CIC postinjection
than those with spinal cord injury.
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 a 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; have weakness of forehead muscles, trouble raising your
eyebrows, drooping eyelids, and any other abnormal facial change;
have symptoms of a UTI and are being treated for urinary
incontinence (symptoms of a UTI 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 such as double vision, blurred vision, decreased eyesight,
drooping eyelids, swelling of your eyelids, and dry eyes; drooping
eyebrows; and upper respiratory tract infection. In adults being
treated for urinary incontinence, other side effects include UTI
and painful urination. In children being treated for urinary
incontinence, other side effects include UTI and bacteria in the
urine. In patients being treated for urinary incontinence, another
side effect includes the inability to empty your bladder on your
own. 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.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
Please see BOTOX® full Product Information,
including Boxed Warning and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Migraine
Impacting one billion people
worldwide, migraine is a neurological disease with recurring
attacks that causes pain and other disabling symptoms. However,
migraine can be treatable. At AbbVie, we are committed to
empowering people in their pursuit of migraine freedom. We advance
science that enables healthcare providers to care for people
impacted across the spectrum of migraine. Through education and
partnerships with the migraine community, we strive to help those
with migraine navigate barriers to care, access effective
treatments and reclaim their 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 2021 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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SOURCE AbbVie