FDA Approval of VYEPTI™ for Migraine Prevention

DEERFIELD – The U.S. Food and Drug Administration (FDA) has approved VYEPTI™ (eptinezumab-jjmr) as a 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. VYEPTI is the first FDA-approved intravenous (IV) treatment for migraine prevention. The drug VYEPTI™ (eptinezumab-jjmr) manufactured by Lundbeck will be available in April 2020.

VYEPTI™ (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

About Migraine

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
• 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, impacting 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, 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.

Comments from Lundbeck

Dr. Deborah Dunsire, President and CEO of Lundbeck, commented, "With the approval of VYEPTI, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The VYEPTI clinical program is the first to demonstrate this early benefit."

Clinical Trials and Efficacy

The efficacy and safety of VYEPTI were demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of VYEPTI 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.

"The PROMISE-2 data showed that many patients can achieve a reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients," said Dr. Peter Goadsby, a professor of neurology at King's College, London and the University of California, San Francisco. "VYEPTI is a valuable addition to the treatment of migraine, which can help reduce the burden of this serious disease."

Adverse Reactions

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.

For more information, please see Prescribing Information.