DEERFIELD, Ill., March 25, 2020 – Lundbeck announced today that findings from the Phase III study PROMISE 2 were published online in Neurology®, the medical journal of the American Academy of Neurology. The study demonstrated that use of VYEPTI™ (eptinezumab-jjmr) as a preventive treatment for chronic migraine in adults significantly reduced the number of mean MMD over months 1-3 (primary endpoint). Chronic migraine was defined as 15-26 headache days per month, of which at least 8 were migraine days. The migraine preventive effect of VYEPTI was statistically significant vs. placebo as early as day 1 and maintained throughout 3 months post-infusion. Approximately one-third of patients on VYEPTI reduced the number of mean MMD by 75 percent or more at month 1. Patients treated with VYEPTI were also more likely to achieve a 75 percent or greater response during months 1-3 compared to placebo. The results are supportive of the findings from the PROMISE 1 study in adults with episodic migraine, which were published online in the journal Cephalalgia on February 19, 2020.
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.
“The PROMISE 2 study found that VYEPTI is associated with a clinically meaningful migraine preventive effect over multiple efficacy measures and is well tolerated in adults with chronic migraine,” said study lead author Richard B. Lipton, M.D., Director, Montefiore Medical Center, Professor of Neurology, Albert Einstein College of Medicine, New York. “The early onset of effect we saw with VYEPTI in this study may translate into meaningful benefits for patients with chronic migraine and may allow them to get back to work, school, household, and family obligations sooner.” Dr. Lipton has consulted for and received research funding from Alder, a company acquired by Lundbeck.
Both evaluated doses (100 mg and 300 mg) met hierarchal endpoints, significantly reducing mean MMD compared with placebo over months 1-3 (p<0.0001). MMD decreased by 7.7 days for 100 mg, 8.2 days for 300 mg, and 5.6 days for placebo.
VYEPTI also demonstrated significant improvements in key secondary endpoints (p<0.0001 for each dose vs. placebo):
VYEPTI was well tolerated in the study with similar rates of treatment-emergent adverse events (TEAE) seen versus placebo. Overall, 47.4 percent of patients experienced at least one TEAE. The incidence of TEAEs was generally balanced among treatment groups: 43.5 percent for 100 mg, 52.0 percent for 300 mg, and 46.7 percent for placebo. Nasopharyngitis was the only TEAE reported for more than 2 percent of VYEPTI treated patients at an incidence of greater than 2 percent over placebo in this study; it occurred in the VYEPTI 300 mg study arm (VYEPTI: 9.4%, placebo: 6.0%).
“The publications of PROMISE 2 and PROMISE 1 in Neurology and Cephalalgia, respectively, underscore the scientific support of VYEPTI as a powerful and generally well-tolerated preventive therapy with 4 infusions a year,” said Roger Cady, M.D., Head of Neurology Medical, Lundbeck Seattle Biopharmaceuticals. “These publications also further highlight the design of VYEPTI as an IV infusion to deliver 100 percent of the medicine into the bloodstream by the end of the infusion.”
The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults with chronic migraine, defined as 15-26 headache days per month, of which at least 8 were migraine days. A total of 1,072 patients received up to two treatments with VYEPTI 100 mg (n=356), VYEPTI 300 mg (n=350), or placebo (n=366), each administered via IV on day 0 and by the end of month 3. Patients with chronic migraine and medication overuse headache, with the exception of overuse of barbiturates or opioids, were eligible for inclusion in the study.
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 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.
VYEPTI™ (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Lundbeck has submitted an application for market authorization of VYEPTI in Canada and also plans to file in the European Union during 2020, followed by the submission of applications in other regions and countries around the world, including China and Japan.
VYEPTITM is indicated for the preventive treatment of migraine in adults.
Important Safety Information
WARNINGS AND PRECAUTIONS
Director, External Affairs & Patient Advocacy
+1 312 802 2906
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.
An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
In the U.S., Lundbeck employs more than 900 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.
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals, and financial performance.
Such forward-looking statements are subject to risks, uncertainties, and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.
Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made considering past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the U.S., prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.