DEERFIELD, Ill., June 13, 2020 – Lundbeck today announced new data analyses on migraine prevention for VYEPTI™ (eptinezumab-jjmr), presented at the 62nd Annual Scientific Meeting of the American Headache Society, which is being held virtually June 13, 2020. The post-hoc findings from the pivotal studies (PROMISE 1 in episodic migraine and PROMISE 2 in chronic migraine) further support VYEPTI as a preventive treatment for migraine disease with onset of action day 1 after administration.
A separate post-hoc subgroup analysis of PROMISE 2 showed that for patients diagnosed with both chronic migraine and medication-overuse headache (MOH), VYEPTI consistently reduced the use of acute headache medications in patients with chronic migraine to levels below MOH thresholds over 6 months. MOH is a chronic daily headache and a secondary disorder, caused by excessive use of acute medications, resulting in headaches and reduced treatment response.
VYEPTI was recently approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. The recommended dose is 100 mg every 3 months; some patients may benefit from a dose of 300 mg. Administered via a 30-minute intravenous (IV) infusion every 3 months, VYEPTI is the first and only IV treatment for migraine prevention.
"We are pleased to present new data at AHS about medication-overuse headache, a complex-to-treat condition in which patients experience chronic headaches as a result of overuse of acute treatments being used to help manage their migraine,” said Roger Cady, M.D., Head of Neurology Medical, Lundbeck Seattle Biopharmaceuticals. “The latest findings for VYEPTI build on previous evidence and further highlight how this new quarterly migraine prevention therapy may help patients with both chronic migraine and medication-overuse headache.”
This post-hoc closed testing analysis of the PROMISE 1 and PROMISE 2 studies looked at the percentage of patients experiencing a migraine, using progressively smaller time intervals, starting with the primary time point (weeks 1-12; days 1-84).
For both studies and both doses, all tests from day 84 working backwards to day 1 alone achieved nominal statistical significance (p<0.05), indicating that VYEPTI was effective beginning on day 1 post-infusion. The response to VYEPTI treatment was sustained for 3 months following the initial dose in both pivotal studies.
This post-hoc subgroup analysis of the PROMISE 2 study evaluated the impact of VYEPTI on the levels of acute headache medication use in adults diagnosed with MOH and chronic migraine. MOH was diagnosed in 431 of 1,072 patients (40.2 percent; 100 mg VYEPTI, n=139; 300 mg VYEPTI, n=147; placebo, n=145).
Patients treated with VYEPTI reduced overuse of acute headache medication within 1 month of initial treatment, and this reduction was sustained over 6 months. Half of the patients receiving VYEPTI were consistently below MOH thresholds for the entire 6-month treatment period, experiencing complete resolution of the MOH diagnosis.
PROMISE 1 and PROMISE 2 were randomized, placebo-controlled studies, both with 6-month double-blind periods, which evaluated the efficacy and safety of VYEPTI as a preventive treatment of episodic migraine and chronic migraine in adults, respectively. In PROMISE 1, episodic migraine was defined as 4-14 headache days per month, of which at least 4 were migraine days. Chronic migraine in PROMISE 2 was defined as 15-26 headache days per month, of which at least 8 were migraine days.
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 most common adverse reactions (≥2% and at least 2% or greater than placebo) were nasopharyngitis and hypersensitivity.
Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (i.e., triptans, ergotamine derivatives), during the trials. Both studies excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, and cerebrovascular disease. 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.
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.
Given via a 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 as an intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg. Dosing should be based on the clinician’s evaluation of specific patient needs.
For more information, please visit www.VYEPTIHCP.com.
VYEPTITM is indicated for the preventive treatment of migraine in adults.
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included angioedema.
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.
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headache 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 as 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 and their relationships, as well as their ability to carry out activities of daily living. More than 157 million work days are lost each year in the U.S. due to migraine.
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