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– UBRELVI® The first and only oral CGRP receptor antagonist (hepant) approved by Health Canada for the acute treatment of migraine
— UBRELVI® It has been shown to reduce or eliminate migraine attacks with a single oral tablet, with the flexibility to take an additional second dose for persistent pain.
MONTREAL, November 16, 2022 /CNW/ – AbbVie (NYSE: ABBV) today announced that Health Canada has approved UBRELVY® (ubrogepant tablet) for the acute treatment of migraine with or without aura in adults.1 UBRELVY® The first orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (hepant) to treat migraine attacks after they start.
An estimated 2.7 million Canadians have been diagnosed with migraine, which understates the current prevalence of migraine.2 Migraine is a complex neurological disorder characterized by recurrent attacks lasting 4-72 hours. It can be defined by symptoms such as moderate and severe intensity of the disease, nausea, vomiting, photophobia and phonophobia.3 It is one of the leading causes of disability in the world.4
“I see firsthand the incredible impact that migraines have on my patients. When you have an attack, some patients seek solitude and withdraw from everything in their lives. It’s unbearable and can affect a person’s relationships with family and friends. , school and work,” said Dr. Jonathan GladstoneMD, FRCPC, Neurologist and Director of the Gladstone Headache Clinic Toronto. “Health of Canada The approval of UBRELVY is an important step in providing physicians with a new migraine-specific option for migraine sufferers. The Gepant class is one of the most highly regarded targeted therapies for the treatment of migraine. I’m excited that there is another treatment option that can help patients successfully manage their migraines.”
Calcitonin gene-related peptide (CGRP) is a neuropeptide of the peripheral and central nervous system. CGRP is released from sensory nerve endings during migraine attacks, particularly from nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, high affinity (Ki = 0.07nM) CGRP receptor antagonist (hepant), which blocks CGRP binding to its receptor and antagonizes CGRP receptor function. UBRELVY® has been shown to reduce or eliminate migraine headaches with a single oral tablet, with the flexibility of taking an additional second dose for persistent pain.1
“Migraine can often be a debilitating disease that affects a person’s ability to work and perform daily activities. Successfully managing migraine attacks when they occur is critical,” he says. Wendy Gerhart, Executive Director, Migraine Canada. “Migraine Canada Welcomes UBRELVI’s approval® in it Canada as a new and innovative treatment method. This will have a positive impact on the migraine community across the country.”
Efficacy of UBRELVY® Two multicenter, randomized, double-blind, placebo-controlled, single-migraine attack studies for the acute treatment of migraine. These studies included patients with a history of migraine with and without aura and with 2 to 8 moderate to severe headaches per month according to the ICHD-3 beta diagnostic criteria. 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 allowed to use standard migraine preventive medications during the study. At baseline, 23% of patients were taking anti-migraine medications. The most commonly used prophylactic drugs were topiramate, onabotulinumtoxinA, propranolol, and amitriptyline.1
“UBRELVI® as the first oral hepant approved in Canada “This is an important milestone in our commitment to bring innovative new medicines to Canadians for the acute treatment of migraine, with the goal of making a significant difference for patients.” Tracy RamseyVice President and General Manager of AbbVie Canada.
About the 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 of the peripheral and central nervous system. CGRP is released from sensory nerve endings during migraine attacks, particularly from nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, high affinity (Ki = 0.07nM) CGRP receptor antagonist (hepant), which blocks CGRP binding to its receptor and antagonizes CGRP receptor function. UBRELVY® It has been shown to reduce or eliminate migraine pain with one oral pill, with the flexibility of taking an additional second dose for persistent pain.
UBRELVY® is against:
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In patients with hypersensitivity to this drug or any of its ingredients, including any non-medicinal ingredient or component of the container
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with the simultaneous use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
Please consult UBRELVY® The product monograph is here.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that address critical health issues today and solve the medical challenges of tomorrow. In addition to the products and services in its Allergan Aesthetics portfolio, we strive to make a tangible impact on people’s lives in several key therapeutic areas: immunology, oncology, neurology, eye care, virology, women’s health and gastroenterology. For more information about AbbVie, visit www.abbvie.ca. Subscribe to AbbVie Canada TwitterFind us on Instagram or LinkedIn.
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2 Ramage-Morin P., & Gilmour, H. (2014). Prevalence of migraine in a 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. Available November 2022. |
3 International Headache Society (IHS) Headache Classification Committee International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. |
4 Steiner, TJ, Stovner, LJ, Jensen, R. et al. Migraine remains the second leading cause of disability in the world and the leading cause of disability among young women: GBD2019 findings. J Headache 21, 137 (2020). https://doi.org/10.1186/s10194-020-01208-0 |
SOURCE AbbVie Canada
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