Health Canada approves Lundbeck's (Pr)VYEPTI; (eptinezumab)--the first and only intravenous preventive treatment for migraine
MONTREAL, Jan. 12, 2021 /PRNewswire/ - Lundbeck is pleased to announce that VYEPTI® (eptinezumab) has been approved by Health Canada for the preventive treatment of migraine in adults who have at least 4 migraine days per month.
Michal Juul Sørensen, Vice President and General Manager of Lundbeck Canada, comments, "This is an important moment in migraine prevention. VYEPTI® is an exciting addition to Lundbeck's biopharmaceutical portfolio—one that brings an additional option to Canadians living with migraine and the physicians who support them."
VYEPTI® is the first Health Canada-approved intravenous (IV) treatment for migraine prevention. Its unique administration delivers prevention of migraine, with effects seen as soon as day one post-infusion through to 3 months.1 Canadian healthcare professionals and people living with migraine will soon have access to this new treatment option that has demonstrated effective therapeutic results in clinical trials. As a 30-minute IV infusion administered every 12 weeks, VYEPTI® offers patients with migraine a preventive therapy through 4 treatments per year.
With a novel route of administration in migraine prevention, VYEPTI® will be complemented by a patient support program to facilitate and support the administration of this IV treatment in people with migraine.
Chair of Migraine Canada and President of the Canadian Headache Society, neurologist Dr. Elizabeth Leroux comments, "With the approval of VYEPTI®, a new IV option has been added to our therapeutic arsenal—a preventive option that has demonstrated 50% and 75% responder rates and good tolerability. This could mean rapid and sustained relief for many people with frequent migraine."
"We are pleased to learn that a new medication to prevent migraine has been approved by Health Canada. Timely and equitable access to new treatment options is necessary for Canadians living with this painful and disabling condition. This is a hopeful time for patients." said Wendy Gerhart, Executive Director at Migraine Canada.
Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of VYEPTI® as early as Day 1 post-infusion. The safety of VYEPTI® was evaluated in 2,076 adult patients with migraine who received at least one dose of VYEPTI®. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
The full VYEPTI® Product Monograph is available on Lundbeck Canada Inc. website.
Migraine is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.5 Migraine has a profound impact on people's lives, their relationships, as well as their ability to carry out activities of daily living. It has been estimated that migraine accounts for 7 million lost working days annually in Canada.4
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centres in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (CAD 3.5 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com/ca/en.
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SOURCE Lundbeck Canada Inc.