Health Canada approves Lundbeck's (Pr)VYEPTI® (eptinezumab)--the first and only intravenous preventive treatment for migraine

MONTREAL, Jan. 12, 2021 /CNW Telbec/ - 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.

About VYEPTI^®
VYEPTI^® is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of VYEPTI^® was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine, which also included patients with a dual diagnosis of chronic migraine and medication overuse headache)^2,3. In both studies, VYEPTI^® met its primary endpoint of decrease in mean monthly migraine days (MMD) over Weeks 1-12.

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.

About migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches, typically accompanied by an array of symptoms including nausea, vomiting, and sensitivity to light or sound. It is estimated to affect 2-3 million Canadians and more than 1.3 billion worldwide, and impacts three times as many women than men.⁴

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

Lundbeck contact
Lundbeck is dedicated to keeping physicians informed about the status and availability of VYEPTI^® in Canada. In addition to requested communications including emails from head office and representatives, physicians can also contact Lundbeck Canada General Inquiries at 1-800-586-2325 Ext. 5.

About Lundbeck
Lundbeck is a global biopharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

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.

References: 

1. VYEPTI^® Product Monograph. Montreal, QC: Lundbeck Canada Inc. January 12, 2021.

2. Ashina M, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).  Cephalalgia. 2020 Mar;40(3):241-254. 

3. Lipton RB, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-1377.

4. Statistics Canada. Health Reports, Vol. 12, No. 2 – Migraine. https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2000002/article/5515-eng.pdf?st=u3fLbUl. Accessed January 7, 2021.

5. Stovner J, et al. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018;17:954-976.

Dr Elizabeth Leroux receives honoraria as a consultant of Lundbeck Canada.

VYEPTI^® is a registered trademark of H. Lundbeck A/S, used under license by Lundbeck Canada Inc.

SOURCE Lundbeck Canada Inc.

Media Relations Contact, Caroline Desautels, Public Relations and Communication Consultant, 514-772-0704, [email protected]