Lundbeck to Showcase New VYEPTI® (eptinezumab-jjmr) Data at 63rd Annual Scientific Meeting of the American Headache Society (AHS)
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.
- Abstract #1000332: Resolution of Migraine Symptoms After Initiating the Preventive Treatment Eptinezumab During a Migraine Attack (oral presentation; abbreviated title).
- Abstract #988822: Eptinezumab for Migraine Prevention in Patients 50 Years or Older: A Subgroup Analysis of PROMISE 1 and PROMISE 2 (poster).
- Abstract #988885: Efficacy and Safety of Eptinezumab in Patients With Migraine and Self-Reported Aura: Post Hoc Analysis of PROMISE 1 and PROMISE 2 (poster).
- Abstract #987552: Cardiovascular Safety of Eptinezumab: A Pooled Analysis of Double-Blind, Randomized, Placebo-Controlled Studies (poster).
- Abstract #991678: Patients With Migraine Who Achieved a ≥75% Reduction in Monthly Migraine Days With Eptinezumab Treatment: Subgroup Analysis of PROMISE 1 and PROMISE 2 (poster).
- Abstract #992268: Likelihood of Continued Response With Treatment in Patients With Chronic Migraine (poster; abbreviated title).
- Abstract #993588: Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE 1 and PROMISE 2 (poster).
- Abstract #996498: Evaluating the Utility of Patient-Identified Most Bothersome Symptom for Migraine Research (poster).
- Abstract #998719: Migraine-Associated Burden After Eptinezumab Treatment in Patients With Chronic Migraine (poster; abbreviated title).
- Abstract #1001664: Identification of Patients With Migraine, Migraine-related Symptoms and Migraine Medication Use Within Electronic Medical Records Using Artificial Intelligence (poster).
- Abstract #1001905: Disparity Between Self-Reported and Functional Disability Among Adults With Migraine (poster).
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 adult 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. 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 billion worldwide and impacts three times as many women than men. In 2016, it was the second leading cause of years lived with disability (YLD) among all diseases and was 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.
Indication and Important Safety Information
VYEPTI® is indicated for the preventive treatment of migraine in adults.
Important Safety Information
- VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included angioedema.
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
- 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.
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.
In the United States, Lundbeck employs more than 1,000 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in a broad range of initiatives each year that support our patient communities.
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