The Journal of the American Medical Association Publishes Data on Efficacy and Safety of Preventive Migraine Treatment VYEPTI® (eptinezumab-jjmr) When Administered During an Active Migraine Attack

DEERFIELD, Ill., June 15, 2021 – The full results from the RELIEF study were published today in The Journal of the American Medical Association (JAMA). VYEPTI® (eptinezumab-jjmr) met both co-primary endpoints, showing early benefit for time to headache pain freedom, and time to the absence of most bothersome symptoms (MBS), compared to placebo. Patients treated with VYEPTI experienced headache pain freedom and absence of their MBS at 2 hours post-infusion, achieving the key secondary endpoints. The RELIEF study evaluated how preventive migraine candidates may benefit from a VYEPTI infusion during an active migraine attack when administered within 1 to 6 hours of a moderate to severe migraine attack. VYEPTI is the first and only intravenous (IV) infusion approved for the preventive treatment of migraine in adults.

“Historically, patients with migraine have had to wait several weeks for the effect of their preventive medications to manifest,” says Paul Winner, D.O., Director of the Palm Beach Headache Center, and one of the lead authors of the study. “The RELIEF data in JAMA validates that treatment with VYEPTI in the midst of a migraine attack may mitigate the duration and most bothersome symptoms associated with the current attack, while still providing the therapeutic benefit of preventing future attacks. Furthermore, an active migraine would not be an obstacle for initiating preventive treatment with VYEPTI.”

Patients receiving a 100 mg VYEPTI infusion during a migraine attack achieved co-primary endpoints of the time to freedom from headache pain (hazard ratio [HR]=1.54, p<0.001) and time to absence of their MBS (HR=1.75, p<0.001) earlier than placebo. Patients receiving VYEPTI reported a median time to headache pain freedom of 4 hours vs. 9 hours among those who received placebo, and a median time of 2 hours to the absence of their MBS vs. 3 hours with placebo.

The key secondary endpoints met statistical significance, demonstrating that at 2 hours after the start of the infusion, headache pain freedom was reported by 23.5% patients receiving VYEPTI and 12.0% receiving placebo (p<0.001), while absence of MBS was reported by 55.5% patients receiving VYEPTI and 35.8% receiving placebo (p<0.001). The exploratory endpoint of time to next migraine was met (10 days with VYEPTI vs. 5 days with placebo).

Consistent with previous pivotal trials, VYEPTI was well-tolerated in the RELIEF study with similar rates of treatment-emergent adverse events (TEAE) seen vs. placebo. In the RELIEF study, TEAE occurred in 10.9% of VYEPTI group and 10.3% of the placebo group. The most frequently reported TEAE in the VYEPTI group was hypersensitivity, 2.1% vs. none in the placebo group.

“We purposefully designed the RELIEF study with the knowledge that patients experiencing high-frequency of migraine attacks could have an active migraine when administered preventive treatment with VYEPTI,” said Roger Cady, M.D., Vice President of Neurology at Lundbeck. “In the RELIEF study, administering VYEPTI during an active migraine resolved headache and migraine-associated symptoms, and extended the time to the next migraine attack vs. placebo. These data provide important insights into the spectrum of therapeutic needs of patients experiencing frequent migraine episodes.”

About the RELIEF Study Publication in JAMA

The RELIEF study (NCT04152083) is a parallel group, double-blind, randomized, placebo-controlled study that evaluated the efficacy and safety of VYEPTI, initiated within 1-6 hours of the onset of a migraine attack in adult patients who are candidates for preventive therapy, experiencing 4 to 15 migraine days per month. Subjects were randomized to receive a single 100 mg dose of VYEPTI or placebo in a 1:1 ratio (n=480) administered via a 30-minute IV infusion.

The RELIEF study met co-primary endpoints of time to headache pain freedom (HR 1.54, p<0.001) and time to absence of MBS (HR 1.75, p<0.001) for VYEPTI-treated patients, compared with placebo. Most Bothersome Symptoms (MBS) include nausea, photophobia, and phonophobia. Patients receiving VYEPTI reported a median time to freedom from headache pain of 4 hours vs. 9 hours among those who received placebo and a median time of 2 hours to the absence of their MBS vs. 3 hours with placebo.

Participants treated with VYEPTI vs. placebo met statistical significance on all secondary endpoints, including:

• Headache pain freedom: 23.5% vs. 12%, respectively, achieved headache pain freedom (p<0.001) at 2 hours post-treatment. This benefit was maintained 4 hours post-treatment (46.6% vs. 26.4%, respectively)
• Absence of MBS: 55.5% vs. 35.8%, respectively, experienced an absence of MBS (p<0.001) at 2 hours post-treatment. This benefit was maintained at 4 hours post-treatment (65.1% vs. 37.5%, respectively)
• Use of rescue medication: Fewer VYEPTI-treated patients (31.5%) vs. placebo (59.9%) required rescue medications within 24 hours of treatment

Safety and tolerability of VYEPTI administered during a migraine attack were also assessed and were comparable to the safety data from two phase III pivotal studies, PROMISE 1 and PROMISE 2. 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.

About VYEPTI®

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 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 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.

Administered as one 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, 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.

VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. VYEPTI is not approved for the acute treatment of migraine.  For more information, please see Prescribing Information and Patient Information or visit www.VYEPTIHCP.com 

About Migraine

Migraine is an 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., more than 1 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 workdays 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

CONTRAINDICATIONS 

• 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.

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 and Patient Information.

Contact

Ashleigh Duchene
Director, External Affairs & Patient Advocacy
aduc@lundbeck.com
+1 312 802 2906

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) 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.

Our approximately 6,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centers in Denmark and California and our production facilities are located in Denmark, France and Italy

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