Vyepti Shows Positive Results in the Treatment of Migraine

The results of the DELIVER study showed that eptinezumab-jjmr (Vyepti) met its primary endpoint in demonstrating the statistically significant superiority of the drug compared to placebo in reducing the number of monthly migraine days over 12 weeks of treatment. DELIVER is a phase 3b, multicenter randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr for individuals with chronic or episodic migraine.

The results of the study were accepted for publication in the Lancet Neurology, according to a press release from H. Lundbeck A/S (Lundbeck).

“We are incredibly proud that our clinical research is recognized by the medical and scientific community. The publication of the DELIVER results by Lancet Neurology is a clear indication that Lundbeck performs clinical research of the highest quality, and that the results of these efforts are relevant to both clinicians and patients,” Johan Luthman, PhD, EVP, and head of research and Development at Lundback, said in a statement.

Investigators studied the efficacy and safety of eptinezumab-jjmr in the 100 mg and 300 mg intravenous infusion dosages in individuals with 2 to 4 documented unsuccessful prior preventive treatment failures in the past 10 years, with at least 2 treatment failures being older oral preventive therapies and at least 1 failure being due to inadequate efficacy. The study included 892 individuals who were randomized to receive eptinezumab-jjmr in either dose or the placebo.

The treatment therapies included propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan, or botulinum toxin A/B, if documented that botulinum toxin was used for chronic migraine.

In addition to achieving the primary outcome, the study also achieved statistical significance on all key secondary outcome measures. The key secondary endpoints included response rates as individuals with 50% or greater reduction from baseline in monthly migraine days, response rates of individuals with 75% or greater reduction from baseline in monthly migraine days, and change from baseline in the number of monthly migraine days.

Additional secondary endpoints included the 6-item Headache Impact test score, migraine-specific quality of life, health-related quality of life visual analogue scale score, health care resources utilization, and Work Productivity and Activity Impairment Questionnaire.

“These results contribute to the expanding body of evidence in support of migraine preventive treatments with anti-CGRP monoclonal antibodies in patients with previous preventive treatment failures to traditional oral medication. The key message from the study results, which is relevant for both physicians and patients, is that even after multiple treatment failures, there is still hope that patients can respond to this new class of anti-CGRP treatments,” Messoud Ashina, MD, professor of Neurology, and lead author on the DELIVER publication, said in a statement.

The safety profile for eptinezumab-jjmr was consistent with the safety profile in the pivotal phase 3 study with eptinezumab-jjmr for the preventive treatment of migraine.

Investigators reported that upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most common treatment-emergent adverse events.

Reference

The primary and key secondary results on Vyepti (eptinezumab-jjmr) from the DELIVER study in patients with migraine and prior preventive treatment failures are now published in the high-impact medical journal Lancet Neurology. Lundbeck, News release. June 15, 2022. Accessed June 27, 2022. https://www.newsroom.lundbeckus.com/news-release/2022/results-from-the-deliver-study-with-vyepti-has-been-published-in-a-top-ranking-medical-journal