- QULIPTA is now the first and only oral calcitonin
gene-related peptide (CGRP) receptor antagonist (gepant) approved
to prevent migraine across all frequencies, including episodic and
chronic.
- Expanded indication provides an additional treatment option
for those with chronic migraine whose frequent disabling attacks
negatively impact performance of daily activities.
- Approval was based on a pivotal Phase 3 clinical trial that
demonstrated statistically significant reduction from baseline in
mean monthly migraine days.
- AbbVie is the only pharmaceutical company to offer three
treatments across the full spectrum of migraine to help patients
living with this debilitating disease.
MONTRÉAL, May 8, 2024
/CNW/ - AbbVie (NYSE: ABBV) announced today that Health Canada
has approved QULIPTA (atogepant) for the prevention of migraine in
adults who have at least four migraine days per
month.1 QULIPTA is the first and only oral,
small-molecule calcitonin gene-related peptide (CGRP) receptor
antagonist (gepant) approved to prevent both episodic and chronic
migraine.
"QULIPTA has been helping thousands of Canadians living with
episodic migraine since December
2022. Now, QULIPTA offers a new option for those with the
most challenging-to-treat chronic migraine," says Rami Fayed,
Vice President and General Manager, AbbVie Canada. "With this
approval, AbbVie is the only pharmaceutical company with three
treatments across the entire migraine spectrum, including QULIPTA
as a preventive treatment for both episodic and chronic migraine,
BOTOX® (onabotulinumtoxinA) our foundational preventive
treatment for chronic migraine, and UBRELVY®
(ubrogepant), an acute treatment for migraine attacks."
QULIPTA's expanded chronic migraine indication is based on the
pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily
in adult patients with chronic migraine, which met its primary
endpoint of statistically significant reduction of -6.9 from
baseline in mean monthly migraine days compared to placebo of -5.1
across the 12-week treatment period.2 The average
monthly migraine days (MMDs) for patients at baseline during the
clinical trial was 19.2.
"Chronic migraine is incredibly debilitating for my patients. It
makes day-to-day activities often unbearable, and isolates you from
friends, family, and work," says Dr Ian
Finkelstein, Medical Director of the Toronto Headache &
Pain Clinic. "I have observed QULIPTA's ability to alleviate the
challenges posed by episodic migraine in many of my patients,
resulting in improved functionality, impressive response rates, and
sustained efficacy. I'm excited to see Health Canada's approval of
QULIPTA for chronic migraine and to be able to offer another
treatment option to patients to help them successfully prevent
their migraines."
QULIPTA blocks CGRP through a once-daily dose and is available
in three strengths for the preventive treatment of episodic
migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA
is indicated for the preventive treatment of chronic migraine. The
overall safety profile of QULIPTA is consistent with the episodic
migraine patient population, with the most common adverse events
including nausea, constipation, diarrhoea, and
fatigue.1
"Bringing new migraine-specific medications to Canadians living
with migraine is critical as so many have yet to find the relief
they seek," says Wendy Gerhart,
Executive Director of Migraine Canada. "Chronic migraine is a
constant struggle for too many. We are pleased to see the approval
of QULIPTA for this indication providing another safe and effective
option and are confident it will have a positive impact on our
community."
About Migraine
Migraine is a complex neurological disease with recurrent
attacks that lasts 4-72 hours. It can be defined by symptoms such
as moderate to severe pain intensity, nausea, vomiting, photophobia
and phonophobia.3 An estimated 2.7 million Canadians are
reported diagnosed with migraine, however the number of people
living with migraine is much higher.4 Episodic migraine
is characterized as having less than 15 headache days per month,
while 15 headache days or more per month, is considered
chronic.5
About QULIPTA
(atogepant)
QULIPTA (atogepant) is the first and only oral, small-molecule
calcitonin gene-related peptide (CGRP) receptor antagonist (gepant)
specifically developed for the preventive treatment of episodic and
chronic migraine. QULIPTA is an orally administered,
small-molecule, selective calcitonin gene-related peptide (CGRP)
receptor antagonist that blocks the binding of the CGRP to its
receptor. CGRP is a neuropeptide that may play a role in migraine
pathophysiology.1
For important safety information, please consult
the QULIPTA Product
Monograph.
About AbbVie in
Neuroscience
At AbbVie, our commitment to people around the world living with
neurological and psychiatric disorders is unwavering. With more
than three decades of experience in neuroscience, we are providing
meaningful treatment options today and advancing innovation for the
future. AbbVie's Neuroscience portfolio consists of approved
treatments in neurological conditions, including migraine, movement
disorders, and psychiatric disorders, along with a robust pipeline
of transformative therapies. We have made a strong investment in
research and are committed to building a deeper understanding of
neurological and psychiatric disorders. Every challenge makes us
more determined and drives us to discover and deliver advancements
for those impacted by these conditions, their care partners, and
clinicians. For more information, visit www.abbvie.ca.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie
Canada on X, Instagram, or LinkedIn.
For more information on AbbVie's complete
migraine portfolio, please visit www.abbvie.ca.
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1 AbbVie Canada. QULIPTA Product
Monograph. May 2024.
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2 AbbVie. Data on File:
ABVRRTI73750
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3 Headache
Classification Committee of the International Headache Society
(IHS) The International Classification of Headache Disorders, 3rd
edition. Cephalalgia. 2018;38(1):1-211. Accessed April
2024.
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4
Ramage-Morin P., & Gilmour, H. (2014). Prevalence of migraine
in the Canadian household population. Health Reports, 25(6):
10-16.
https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-eng.pdf?st=CSyp19VF.
Accessed April 2024.
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5 Migraine
Canada. The Migraine Family: categories and groups. Retrieved from
https://migrainecanada.org/posts/the-migraine-tree/roots/migraine-categories/the-migraine-family-categories-and-groups/.
Accessed April 2024.
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SOURCE AbbVie Canada