DEERFIELD, Ill., June 9, 2022 – Lundbeck today announced data on VYEPTI® (eptinezumab-jjmr) will be presented at the 64th Annual Scientific Meeting of the American Headache Society (AHS) taking place from June 9-12, 2022. A total of nine poster presentations will be shared to highlight clinical data and real-world analyses of eptinezumab as a preventive migraine treatment in adults.
“These data continue to show the clinical benefit of VYEPTI as a preventive treatment option for people with migraine,” said Marija Geertsen, M.D., Vice President, U.S. Medical Affairs, Lundbeck. “We remain committed to evolving and improving migraine care for those who are highly impacted by migraine and seeking different options to help break the vicious cycle of increasing migraine attacks and more acute treatment use.”
Key abstracts include:
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.
“As a physician treating migraine patients every day, it is great to see the growing real-world and clinical evidence supporting the role eptinezumab can play in migraine prevention,” said Paul K. Winner, DO, FAAN, FAHS, Palm Beach Headache Center. “These data contribute to our long-term understanding of VYEPTI and the people who may benefit from this treatment.”
The full range of eptinezumab-related data to be presented by Lundbeck at AHS 2022 is listed below.
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 deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion.
The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE 1 and chronic migraine in PROMISE 2.
In PROMISE 1, a total of 665 patients were randomized to receive placebo (n=222), 100 mg VYEPTI (n=221), or 300 mg VYEPTI (n=222) every 3 months for 12 months. PROMISE 2 included a total of 1,072 patients who were randomized to receive placebo (n=366), 100 mg VYEPTI (n=356), or 300 mg VYEPTI (n=350) every 3 months for 6 months. The primary endpoint in each study was the change from baseline in mean monthly migraine days (MMD) over Months 1-3. The primary endpoint was met in both episodic and chronic migraine. In PROMISE 2, the study population included patients with a dual diagnosis of chronic migraine and medication-overuse headache attributable to overuse of acute medications: triptans, ergotamine, or combination analgesics greater than 10 days per month.
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.
VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). 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.
Indication and Important Safety Information
VYEPTI® (eptinezumab-jjmr) 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 anaphylaxis and 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. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
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.
VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Prescribing Information and Patient Information or visit www.VYEPTIHCP.com
DELIVER (NCT04418765) is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of VYEPTI in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days per month and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes. Patient who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical record or by physician's confirmation specific to each treatment in the past 10 years.
In the study, 892 patients were randomized to receive eptinezumab 100mg or 300mg or placebo by intravenous (IV) infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures, respectively. The primary endpoint was change from baseline in the number of monthly migraine days over weeks 1-12. Key secondary endpoints included response rates for patients with 50% or greater reduction from baseline in MMDs (weeks 1–12), response rates for patients with 75% or greater reduction from baseline in MMDs (weeks 1–12), and change from baseline in the number of MMDs (Weeks 13–24). Other secondary endpoints assessed the effect of VYEPTI vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, Health care resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI).
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.1 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.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study.2 Migraine has a profound impact on peoples’ lives, their relationships, as well as their ability to carry out activities of daily living.3 More than 157 million workdays are lost each year in the U.S. due to migraine.1
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