New Data Presented at 2021 American Academy of Neurology (AAN) Annual Meeting Shows VYEPTI® (eptinezumab-jjmr) Demonstrated Earlier Time to Freedom from Headache Pain and Absence of Most Bothersome Symptoms Compared to Placebo When Initiated...

New Data Presented at 2021 American Academy of Neurology (AAN) Annual Meeting Shows VYEPTI® (eptinezumab-jjmr) Demonstrated Earlier Time to Freedom from Headache Pain and Absence of Most Bothersome Symptoms Compared to Placebo When Initiated During Migraine Attack in Patients Who Were Candidates for Preventive Therapy

Lundbeck today announced new data from two abstracts for VYEPTI® (eptinezumab-jjmr), presented at the 2021 American Academy of Neurology (AAN), which is being held virtually from April 17 – 22. The findings are from RELIEF (NCT04152083), a parallel group, double-blind, randomized, placebo-controlled study that evaluated the efficacy and safety of VYEPTI – the first and only intravenous (IV) preventive treatment for migraine – when administered within 1 to 6 hours of a moderate to severe migraine attack in patients eligible for migraine prevention. Time to freedom from headache pain and time to absence of the patients’ most bothersome symptom (MBS) were the co-primary endpoints used to evaluate VYEPTI in the study. The MBS was the individual patient’s choice between photophobia, phonophobia, and nausea.

In the first abstract, 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=0.0006) and time to absence of their MBS (HR=1.75, p<0.0001) earlier than placebo. Patients receiving VYEPTI reported a median time to headache pain freedom of 4 hours versus 9 hours among those who received placebo and a median time of 2 hours to the absence of their MBS versus 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=0.0009), while absence of MBS was reported by 55.5% patients receiving VYEPTI and 35.5% receiving placebo (p<0.0001). Consistent with VYEPTI pivotal trials, VYEPTI was well-tolerated in the RELIEF study, with similar rates of treatment-emergent adverse events (TEAE) seen versus placebo.

A second abstract looking at exploratory endpoints demonstrated that, when initiated during a migraine, VYEPTI delayed the time to next migraine by a median of 10 days compared to 5 days with placebo. It also showed that four-weeks post-infusion, VYEPTI produced a clinically meaningful improvement in the 6-item Headache Impact Test (HIT-6) total score, compared with placebo (mean change of -8.7 vs. -4.5, respectively).

“Even though migraine disease remains one of the most common and debilitating neurological disorders globally, many patients do not receive preventive treatment that may reduce the frequency of attacks,” said Peter McAllister, M.D., Co-Founder and Chief Medical Officer at the New England Institute for Neurology and Headache, Stamford, CT, and one of the lead study authors. “The RELIEF data shows that preventive migraine candidates could benefit from treatment even in the midst of a migraine attack – the medication has the potential to still provide a therapeutic benefit in preventing future attacks.”

About the RELIEF Study

In November 2019, Lundbeck initiated the RELIEF study assessing the efficacy and tolerability of VYEPTI initiated during a migraine attack in patients who are candidates for preventive therapy, experiencing 4-15 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) by a 30-minute IV infusion within 1 to 6 hours of migraine-attack onset. The total study duration was 4 to 12 weeks, including up to an 8-week screening period, with clinic visits occurring on Screening, Day 0 (dosing day; patients were monitored at the study site for at least 4 hours after the infusion), and Week 4. Patients were allowed to utilize acute rescue medication 2 hours after infusion.

The co-primary efficacy endpoints of the study were the time to headache pain freedom and the time to absence of the most bothersome symptom, without the need for rescue medication, through 48 hours following treatment administration. Key secondary efficacy endpoints included: headache pain freedom and absence of the most bothersome symptoms 2 hours after treatment; headache pain freedom and absence of most bothersome symptoms 4 hours after treatment; and the use of rescue medication within 24 hours of treatment. The co-primary and key secondary endpoints met statistical significance in the RELIEF study.

The study also examined changes in HIT-6 total scores from baseline. At the time of screening, the investigators assessed the impact of headache on the daily lives of the participants, as measured by the HIT-6 total score, which produces a range from 36 to 78. The mean HIT-6 total scores at screening indicated severe life impact (65.1, VYEPTI; 64.8, placebo). Safety and tolerability of VYEPTI administered during a migraine attack also were 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.

Efficacy and Safety of VYEPTI during a Migraine Attack (Winner P, et al.)

Patients receiving a 100 mg VYEPTI infusion during a migraine attack achieved co-primary endpoints of the time to freedom from headache pain (HR=1.54, p=0.0006) and time to absence of their MBS (HR=1.75, p<0.0001) earlier than placebo. At 2 hours post treatment, 23.5% of VYEPTI-treated patients reported headache pain freedom versus 12.0% in the placebo group (p=0.0009); 55.5% in the VYEPTI group reported an absence of the most bothersome symptom, compared with 35.5% in the placebo group (p<0.0001). These results remained significant at the 4-hour timepoint. In addition, significantly fewer patients treated with VYEPTI versus placebo used rescue medication within 24 hours of treatment (31.5% vs. 59.9%, respectively; p<0.0001). Treatment-emergent adverse events were comparable, occurring in 10.9% of VYEPTI-treated patients and 10.3% of patients in the placebo group. No serious adverse events occurred.

Prolonging the Time to Next Migraine and Improving HIT-6 Outcomes (McAllister P, et al.)

The median time to the next migraine attack, an exploratory endpoint, was 10 days in the VYEPTI group and 5 days in the placebo group. Four-weeks post-infusion, VYEPTI produced a clinically meaningful improvement in HIT-6 total score, compared with placebo (mean change from baseline of -8.7 vs. -4.5, respectively).

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 developed for administration by IV infusion to deliver 100 percent of the medication quickly into the blood stream.

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 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 and launched in April on the US market – the only market where it is currently available. 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 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 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.

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.

In the United States, Lundbeck employs more than 1,000 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.

For additional information, we encourage you to visit us at www.lundbeckus.com, subscribe to our newsletter at Newsroom.LundbeckUS.com, and connect with us on LinkedIn at @LundbeckUS and Twitter at @LundbeckUS.

© 2021 Lundbeck. All rights reserved. VYEPTI is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100509

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