NORTH CHICAGO, Ill.,
Sept. 28, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that the U.S. Food and Drug
Administration (FDA) approved QULIPTA™ (atogepant) for the
preventive treatment of episodic migraine in adults.1
QULIPTA is the first and only oral calcitonin gene-related peptide
(CGRP) receptor antagonist (gepant) specifically developed for the
preventive treatment of migraine.2
Experience the interactive Multichannel News Release here:
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"Millions of people living with migraine often lose days of
productivity each month because attacks can be debilitating.
QULIPTA can help by reducing monthly migraine days with a
once-daily, oral dose that works quickly and continuously," said
Michael Severino, M.D., vice
chairman and president, AbbVie. "We are proud that AbbVie is now
the only pharmaceutical company to offer three products across the
full spectrum of migraine treatment, which include preventive
therapies for chronic and episodic migraine and an acute treatment
for migraine attacks."
The approval is supported by data from a robust clinical program
evaluating the efficacy, safety and tolerability of QULIPTA in
nearly 2,000 patients who experienced 4 to 14 migraine days per
month, including the pivotal Phase 3 ADVANCE study — which was
published in The New England Journal of Medicine — the
pivotal Phase 2b/3 study, and the
Phase 3 long-term safety study.1,2
"When I have a migraine attack, my 5-year-old daughter doesn't
understand why I can't take her to a birthday party or to the park.
It's heartbreaking when I have to tell her I need to be away from
her because my eyes feel like they're going to explode out of my
head," said Kelsi Owens, an ADVANCE
trial participant who has lived with migraine for nearly three
decades. "During the trial while taking QULIPTA, I had many fewer
migraine days. For the first time ever, I don't have difficulty
doing my daily activities and I don't have to worry as much that a
migraine attack will cause me to miss important events with family
and friends."
Migraine is a complex disease with recurrent attacks that are
often incapacitating and characterized by severe, throbbing
headache pain as well as compounding associated symptoms like
extreme sensitivity to light, sound or nausea.4 It is
highly prevalent, affecting more than 1 billion people worldwide,
including 39 million people in the U.S. alone,5 and is
the highest cause of disability worldwide for people under 50 years
of age.6,7
"This approval reflects a broader shift in the treatment and
management paradigm for the migraine community. QULIPTA provides a
simple oral treatment option specifically developed to prevent
migraine attacks and target CGRP, which is believed to be crucially
involved in migraine in many patients," said Peter J. Goadsby, M.D., Ph.D., D.Sc.,
neurologist and professor at University of
California, Los Angeles, and King's College, London, who earned the prestigious Brain Prize
in 2021 for his revolutionary research about CGRP's role in
migraine attacks and co-authored the ADVANCE study.
"I'm particularly encouraged by the convenience of the oral
daily use of QULIPTA, its rapid onset of significant efficacy, and
its safety and tolerability as well as its high patient response
rates. This is a milestone in preventive migraine treatment that I
hope will help many patients for years to come,"
Goadsby said.
Highlights from the clinical program supporting the approval
and additional data analysis include:
- In the pivotal Phase 3, multicenter, randomized, double-blind,
placebo-controlled, parallel-group ADVANCE trial, the primary
endpoint was change from baseline in mean monthly migraine days
across the 12-week treatment period. All QULIPTA dose groups met
the primary endpoint and demonstrated statistically significant
reductions in mean monthly migraine days compared to placebo.
Patients treated with 60 mg of QULIPTA across 12 weeks experienced
a 4.2-day reduction from baseline of 7.8.1
- A key secondary endpoint in the ADVANCE trial measured the
proportion of patients that achieved a ≥50% reduction in monthly
migraine days across the 12-week treatment period. The trial
demonstrated that 56%/59%/61% of patients in the 10 mg/30 mg/60 mg
QULIPTA arms, respectively, achieved a 50-100% reduction, compared
to 29% of patients in the placebo arm (all dose groups vs. placebo,
p<.001).1
- All doses were well tolerated in the ADVANCE trial and pivotal
Phase 2b/3 clinical trial evaluating
the efficacy, safety and tolerability of orally administered
QULIPTA. Adverse reactions in both studies (incidence at least 2%
and greater than placebo) included nausea (5-9% across all doses
versus 3% for placebo), constipation (6% across all doses versus 1%
for placebo), fatigue/somnolence (4-6% across all doses versus 3%
for placebo) and decreased appetite (1-2% across all doses versus
<1% for placebo). The adverse reactions that most commonly led
to discontinuation were constipation (0.5%), nausea (0.5%) and
fatigue/somnolence (0.5%).1
- The pivotal Phase 2b/3 trial
demonstrated that all active treatment arms met the primary
efficacy endpoint of change from baseline in mean monthly migraine
days with significantly greater reductions in mean monthly migraine
days across the 12-week treatment period for all three QULIPTA
treatment groups compared with placebo. All three QULIPTA treatment
groups also met the secondary efficacy endpoint of change from
baseline in mean monthly headache days.1
More information about the clinical program can be found on
www.clinicaltrials.gov (NCT03777059, NCT02848326 and
NCT03700320).
About QULIPTA™
QULIPTA™ (atogepant) is the first and only oral calcitonin
gene-related peptide (CGRP) receptor antagonist (gepant)
specifically developed for the preventive treatment of episodic
migraine. CGRP and its receptors are expressed in regions of the
nervous system associated with migraine pathophysiology, and
studies have shown that CGRP levels are elevated during migraine
attacks. QULIPTA blocks CGRP through a once-daily dose and is
available in three strengths – 10 mg, 30 mg and 60 mg.
QULIPTA will be available in early October 2021. AbbVie believes people living with
migraine should have access to all new medications for this
debilitating disease. Visit www.QULIPTA.com for more
information.
QULIPTA™ Indication
QULIPTA is a calcitonin gene-related peptide receptor antagonist
indicated for the preventive treatment of episodic migraine in
adults.
IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS
The most common adverse reactions (≥4% and greater than placebo)
are nausea, constipation, and fatigue.
DOSAGE AND ADMINISTRATION:
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: 10 mg once
daily.
Strong and Moderate CYP3A4 Inducers: 30 mg or 60 mg once daily.
OATP Inhibitors: 10 mg or 30 mg once daily.
USE IN SPECIFIC PATIENT POPULATIONS
Severe Renal Impairment or End-Stage Renal Disease: 10 mg once
daily.
Avoid use in patients with severe hepatic impairment.
Full prescribing information can be found here.
More information about QULIPTA is available for healthcare
professionals at www.QULIPTAHCP.com.
BOTOX® Indication
BOTOX® is a prescription medicine that is injected into muscles
and used:
- 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
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).
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.
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 its
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.
The dose of BOTOX® is not the same as, or comparable to, any
other botulinum toxin product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, or 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 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; 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 have 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 injection; take muscle relaxants; take allergy or
cold medicines; take sleep medicine; take aspirin-like products or
blood thinners.
Other side effects of BOTOX® include: dry mouth,
discomfort or pain at injection site, tiredness, headache, neck
pain, eye problems: double vision, blurred vision, decreased
eyesight, drooping eyelids, swelling of your eyelids, dry eyes;
drooping eyebrows.
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 Prescribing Information including
Boxed Warning and Medication Guide.
UBRELVY® Indication
UBRELVY® (ubrogepant) is indicated for the acute treatment
of migraine with or without aura in adults. UBRELVY® is not
indicated for the preventive treatment of migraine.
IMPORTANT SAFETY INFORMATION
Contraindication: Concomitant use of strong CYP3A4
inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
Adverse Reactions: The most common adverse reactions were
nausea (4%) and somnolence (3%).
Please see UBRELVY® full Prescribing Information.
About AbbVie in Migraine
Impacting one billion people worldwide, migraine is a
neurological disease with recurring attacks that cause pain and
other disabling symptoms.5 However, migraine can be
treatable. At AbbVie, we are committed to empowering people living
with migraine disease. 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 reduce the impact of
migraine on their lives.
Our portfolio of therapies, which serves the varying needs of
people living with migraine, includes BOTOX®
(onabotulinumtoxinA), the first FDA-approved, preventive treatment
for adults with chronic migraine; UBRELVY® (ubrogepant),
the first FDA-approved oral calcitonin gene-related peptide (CGRP)
receptor antagonist (gepant), indicated for the acute treatment of
migraine with or without aura in adults; and QULIPTA™ (atogepant),
the first and only oral CGRP antagonist specifically developed for
the preventive treatment of episodic migraine in adults.
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, 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,
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.
References:
1. QULIPTA™ (atogepant) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
2. AbbVie. (2021, March 30).
U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for
the Preventive Treatment of Migraine. Available at:
https://news.abbvie.com/news/press-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-preventive-treatment-migraine.htm
3. ClinicalTrials.gov. Study to Evaluate the Safety and
Tolerability of Treatment With Atogepant 60 mg Daily for the
Prevention of Migraine in Participants With Episodic Migraine.
Available at:
https://clinicaltrials.gov/ct2/show/results/NCT03700320
4. Headache Classification Committee of the International
Headache Society (IHS) The International Classification of Headache
Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
5. Migraine Research Foundation. Migraine Facts. Available at:
https://migraineresearchfoundation.org/about-migraine/migraine-facts/#:~:text=Migraine%20is%20an%20extraordinarily%20prevalent,U.S.%20and%201%20billion%20worldwide.
6. GBD 2016 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 328 diseases and
injuries for 195 countries, 1990-2016: a systematic analysis for
the Global Burden of Disease Study 2016. Lancet.
2017;390:1211-1259.
7. Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., &
Katsarava, Z. Migraine is first cause of disability in under 50s:
Will health politicians now take notice? J Headache Pain.
2018;19:17.
SOURCE AbbVie
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SOURCE AbbVie