Lundbeck has announced positive results from the DELIVER study assessing the efficacy and safety of Vyepti (eptinezumab) 100mg and 300mg IV infusion in patients with chronic or episodic migraine who had experienced two to four previous preventive treatment failures due to lack of efficacy or intolerable side effects.
The study met its primary objective of demonstrating superiority of Vyepti versus placebo in reducing the number of monthly migraine headache days (MMDs) over 12 weeks of treatment. In the study, treatment with Vyepti 100mg and 300mg reduced monthly migraine days by 4.8 and 5.3 days (P<0.0001), respectively, compared with a reduction of 2.1 days with placebo.
In addition, the DELIVER study achieved statistical significance on all key secondary outcome measures. Specifically, more patients achieved the clinically relevant 50% or greater reduction in migraine days over weeks 1-12 after receiving Vyepti 100mg (42.1%) and 300mg (49.5%) than patients receiving placebo (13.1%).
The safety profile of Vyepti observed in the DELIVER study was consistent with the safety profile observed in the pivotal phase III studies with Vyepti for the preventive treatment of migraine.
“The strong outcome in this hard-to-treat population highlights the potential of Vyepti as a powerful treatment option.”
“We are encouraged by the efficacy and safety results from the DELIVER study for Vyepti in migraine patients, who have experienced several other preventive treatment failures. Failure of preventive oral medication is common among patients with migraine and represents a huge unmet medical need. The strong outcome in this hard-to-treat population highlights the potential of Vyepti as a powerful treatment option,” says Johan Luthman, EVP and Head of Research & Development in Lundbeck.