DEERFIELD, Ill., June 3, 2021 – Lundbeck today announced that new data on migraine prevention with VYEPTI® (eptinezumab-jjmr) will be presented at the 63rd Annual Scientific Meeting of the American Headache Society (AHS), taking place virtually from June 3-6, 2021. VYEPTI is the first and only FDA-approved intravenous (IV) preventive migraine treatment for adults.
The data showcased at AHS include one oral presentation and 10 posters. The oral presentation will outline an exploratory analysis of the RELIEF study, which assessed the efficacy of VYEPTI initiated during a migraine attack in adult patients who are candidates for preventive therapy. Several posters will feature post-hoc analyses of the pivotal phase III PROMISE 1 and PROMISE 2 clinical studies.
“Our clinical program, including these new data presented at AHS, continues to demonstrate the growing number of insights into the important role VYEPTI can play in reducing the frequency of migraine,” said Roger Cady, M.D., Vice President of Neurology at Lundbeck. “This new data further contributes to our long-term understanding of VYEPTI, its tolerability, safety and efficacy profile, and the patients who may respond to treatment.”
The full range of data to be presented at AHS 2021 is listed below.
Lundbeck will also be hosting an on-demand symposium available for AHS meeting attendees, titled “Treat to Target: Migraine Prevention,” for healthcare professionals involved with the diagnosis and treatment of migraine. The panel of headache experts will discuss importance of individualized management of migraine prevention, through the use of patient cases.
VYEPTI (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was developed for administration by IV infusion to deliver 100 percent of the medication quickly into the blood stream.
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). VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE 1 and PROMISE 2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions.
Administered as one 30-minute IV infusion every 3 months, VYEPTI offers patients with migraine a preventive therapy with 4 infusions a year. The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information.
VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020 and launched in April on the US market – the only market where it is currently available. VYEPTI is not approved for the acute treatment of migraine. For more information, please see Prescribing Information and Patient Information or visit www.VYEPTIHCP.com
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 approximately 39 million people in the U.S. and more than 1.3 billion worldwide and impacts three times as many women than men. It 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. Migraine has a profound impact on patients’ lives, their relationships, as well as their ability to carry out activities of daily living. More than 157 million workdays are lost each year in the U.S. due to migraine.
VYEPTI® is indicated for the preventive treatment of migraine in adults.
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H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) 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 6,000 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 centers in Denmark and California and our production facilities are located in Denmark, France and Italy.
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