- UBRELVY® is the first and only
oral CGRP receptor antagonist (gepant) approved by Health Canada
for the acute treatment of migraine
-- UBRELVY® was demonstrated
to reduce or eliminate migraine pain with a single oral tablet,
with the flexibility to take an optional second dose for persistent
pain
MONTREAL, Nov. 16,
2022 /CNW/ - AbbVie (NYSE: ABBV) announced today
that Health Canada has approved
UBRELVY® (ubrogepant tablet) for the acute
treatment of migraine, with or without aura, in adults.1
UBRELVY® is the first orally-administered
calcitonin gene-related peptide (CGRP) receptor antagonist (gepant)
for the treatment of migraine attacks once they start.
An estimated 2.7 million Canadians have been diagnosed with
migraine, which is estimated to underrepresent today's migraine
prevalence.2 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 It is one of the leading causes
of disability in the world.4
"I see first-hand the incredible impact migraines can have on my
patients. When you suffer an attack, some patients are forced
to seek solitude and remove themselves from everything in their
lives. It can be unbearable and impact one's interaction with
family, friends, school and work," said Dr. Jonathan Gladstone, MD, FRCPC, neurologist and
Director of the Gladstone Headache Clinic in Toronto. "Health Canada's approval of UBRELVY is an important
step forward allowing physicians to provide a new migraine-specific
option for migraine sufferers. The gepant class is one of the most
evaluated targeted therapies for migraine treatment. I'm excited to
have another treatment option available to help patients
successfully manage their migraines."
Calcitonin gene-related peptide (CGRP) is a neuropeptide present
in the peripheral and central nervous system. CGRP is released from
sensory nerve endings during a migraine attack, particularly the
nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is
a small molecule, high affinity (Ki = 0.07nM)
CGRP receptor antagonist (gepant) that blocks the binding of CGRP
to its receptor and antagonizes CGRP receptor function. UBRELVY®
was demonstrated to reduce or eliminate migraine pain with a
single oral tablet, with the flexibility to take an optional second
dose for persistent pain.1
"Migraine can often be a debilitating disease that can impact a
person's ability to function and perform their daily routines.
Being able to successfully address migraine attacks as they occur
is essential," says Wendy Gerhart,
Executive Director, Migraine Canada. "Migraine Canada welcomes the approval of
UBRELVY® in Canada
as a new and innovative treatment option. This will have a positive
impact for the migraine community across the country."
The efficacy of UBRELVY® for the acute treatment
of migraine was demonstrated in two multicenter, randomized,
double-blind, placebo-controlled, single migraine attack studies.
These studies enrolled patients with a history of migraine with and
without aura, according to the ICHD-3 beta diagnostic criteria, and
who experienced 2 to 8 migraine attacks per month with moderate to
severe headache pain. In Study 1 (ACHIEVE I),
patients were randomized to receive UBRELVY 50 mg or
100 mg or placebo; and in Study 2 (ACHIEVE II),
patients were randomized to receive UBRELVY 50 mg or placebo.
Patients were permitted to use standard migraine preventive
medications during the study. At baseline, 23% percent of patients
were taking preventive medications for migraine. The most commonly
used preventive medications were topiramate, onabotulinumtoxinA,
propranolol, and amitriptyline.1
"UBRELVY® as the first oral gepant approved in
Canada for the acute treatment of
migraine is an important milestone in our commitment to bring
innovative new medicines to Canadians with the goal make a
meaningful difference for patients," says Tracey Ramsay, Vice President and General
Manager, AbbVie Canada.
About UBRELVY® (ubrogepant
tablet)
1
UBRELVY® (ubrogepant
tablet) is indicated for the acute treatment of migraine, with or
without aura, in adults.
Calcitonin gene-related peptide (CGRP) is a neuropeptide present
in the peripheral and central nervous system. CGRP is released from
sensory nerve endings during a migraine attack, particularly the
nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is
a small molecule, high affinity (Ki = 0.07nM)
CGRP receptor antagonist (gepant) that blocks the binding of CGRP
to its receptor and antagonizes CGRP receptor function.
UBRELVY® was demonstrated to reduce or eliminate
migraine pain with a single oral tablet, with the flexibility to
take an optional second dose for persistent pain.
UBRELVY® is contraindicated:
- In patients with hypersensitivity to this drug or to any
ingredient in the formulation, including any non-medicinal
ingredient, or component of the container
- With concomitant use of strong CYP3A4 Inhibitors (e.g.,
ketoconazole, itraconazole, clarithromycin)
Please consult the UBRELVY® Product Monograph
here.
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.ca. Follow AbbVie Canada on Twitter,
on Instagram or find us on LinkedIn.
__________________________________
1 UBRELVY Product Monograph. AbbVie Canada. November
2022.
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2 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 November 2022.
|
3 Headache Classification Committee
of the International Headache Society (IHS) The International
Classification of Headache Disorders, 3rd edition.
Cephalalgia. 2018;38(1):1-211.
|
4 Steiner, T.J., Stovner, L.J.,
Jensen, R. et al. Migraine remains second among the world's causes
of disability, and first among young women: findings from GBD2019.
J Headache Pain 21, 137 (2020).
https://doi.org/10.1186/s10194-020-01208-0
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SOURCE AbbVie Canada