DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck today announced that VYEPTI™ (eptinezumab-jjmr), the first and only intravenous (IV) treatment for migraine prevention, is now commercially available in the U.S. and can be obtained via select specialty distributors and specialty pharmacies.
“We are pleased to announce the availability of VYEPTI for migraine prevention in the U.S., along with a suite of online resources for patients and their healthcare providers, which we hope will be useful to learn more about this new treatment option,” said Peter Anastasiou, Lundbeck’s Executive Vice President, North America. “While we recognize and face the challenges of this global pandemic together, Lundbeck remains steadfast in our commitment to bring VYEPTI to patients.”
Responding to challenges posed by COVID-19, the company has adjusted its launch activities to largely center on delivering content virtually, digitally and socially, so patients and their healthcare providers are informed about this new treatment option. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) on February 21, 2020, for the preventive treatment of migraine in adults.
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 clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of VYEPTI (100 mg and 300 mg) as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for VYEPTI than with placebo for most of the first 7 days. 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.
Resources for Patients and Healthcare Providers
The VYEPTI GO Patient Support Program was developed to offer resources and support during a patient’s VYEPTI treatment journey. VYEPTI GO provides access to patient navigators and registered nurses that are available by phone 6 days per week to answer questions and direct patients to helpful resources regarding VYEPTI, migraine, and IV education. The Program also offers text and email communications to assist patients with appointment reminders. Patients can enroll by calling 833-4-VYEPTI and selecting option 2.
Through the VYEPTI Copay Assistance Program, eligible commercially insured patients may pay as little as $5 per infusion every 3 months for VYEPTI.* Patients can check eligibility requirements and enroll in the program by calling 833-4-VYEPTI and selecting option 3.
For U.S. healthcare providers and office staff, Lundbeck’s field force is available to conduct online appointments and educational sessions with healthcare providers. Additionally, Lundbeck has created VYEPTI CONNECT™, an optional program that provides support throughout the process of initiating treatment with VYEPTI—from benefit investigation through appeal—as well as information about financial assistance that may be available for eligible patients, support for prior authorizations or other access inquiries. Healthcare providers or their staff can also reach out to VYEPTI CONNECT for any questions on how to access VYEPTI via specialty distributors or specialty pharmacies. For more information, healthcare providers can visit www.VYEPTIHCP.com or call 833-4-VYEPTI and select option 1.
“It is a new era in the treatment of migraine disease. We now better understand the pathways of migraine and have a variety of innovative medicines and devices that can prevent and treat migraine attacks, including Lundbeck’s new treatment. We thank the companies, scientists and patients that have contributed to the research that is making effective migraine management a real possibility for millions of Americans,” said Kevin Lenaburg, Executive Director for the Coalition for Headache and Migraine Patients (CHAMP). “I encourage everyone with migraine to talk with their healthcare provider about what option will work best for them.”
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 powerful and generally well-tolerated 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.1 Dosing should be based on the clinician’s evaluation of specific patient needs.
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.
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 work days 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 pharmaceutical 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.
Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind. Read more at www.lundbeck.com/global/about-us/progress-in-mind. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.
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 U.S. actively engages in a broad range of initiatives each year that support our patient communities. For additional information, we encourage you to visit at www.lundbeckus.com, subscribe to our newsletter at newsroom.lundbeckus.com, and connect with us on Twitter at @LundbeckUS.
Safe Harbor/Forward-Looking Statements
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.
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