H. Lundbeck A/S announced that the results from the DELIVER study have been recognized for their importance for the scientific and medical community. The results from the clinical study with Vyepti (eptinezumab) were accepted for publication in the prestigious journal Lancet Neurology, one of the most cited medical journals within neurology. The DELIVER study results were published online on June 15.
The DELIVER study investigated the efficacy and safety of Vyepti 100 mg and 300 mg IV infusion in patients with chronic or episodic migraine who had experienced 2-4 previous preventive treatment failures due to lack of efficacy or intolerable side effects. The DELIVER study met its primary objective of demonstrating statistically significant superiority of Vyepti versus placebo in reducing the number of monthly migraine days (MMDs) over 12 weeks of treatment and it also achieved statistical significance on all key secondary outcome measures. While 42% to 49% of patients who received Vyepti in the DELIVER study achieved a =50% reduction in MMDs over 12 weeks, other studies with subcutaneously administered monoclonal antibodies targeting CGRP or its receptor (erenumab, fremanezumab, and galcanezumab) in patients with migraine and 2-4 previous preventive treatment failures migraine report that 30-38% of patients achieved a =50% reduction in MMDs.
In addition to the reduction in frequency of migraine days for patients treated with Vyepti, a larger reduction in the percentage of severe attacks for the remaining headache episodes compared to placebo was observed.