Vyepti(eptinezumab)

Neurology· 1298 cited findings· 2 source documents

What the regulatory reviews say

Vyepti (eptinezumab) is a drug indicated for the prophylaxis of migraine. Efficacy results from clinical trials demonstrated a mean change from baseline in monthly migraine days of -4.29, with a mean difference from placebo of -1.11. The p-value for ALD403 300 mg versus placebo was 0.0001. The observed 50% responder rate for the fourth quartile of AUC0-12wk (Weeks 1-12) was 57%, compared to 39% for placebo during the same period. The observed 75% responder rate for the third quartile of AUC0-12wk (Weeks 1-12) was 33%, compared to 17% for placebo.

Safety data from a total of 2867 patients, including 2076 eptinezumab-treated patients, showed an overall incidence of treatment-emergent anti-drug antibodies (ADA) of 15.9%, with an overall incidence of neutralizing antibodies (NAb) of 6.2%. The incidence of treatment-emergent mild or moderate adverse events coded to hypersensitivity was 1.2%. The marketing authorization application was submitted on 16 November 2020, and a positive opinion from the CHMP was issued on 11 November 2021. The FDA application (BLA761119) was submitted on 2/21/2019 and completed review on 1/31/2020.

Key figures — cited to the source page

Mean change from baseline in monthly migraine days	-4.29	H. Lundbeck A/S — Vyepti FDA Review (BLA761119, ORIG 1, 2020, p.50
Mean difference from placebo in monthly migraine days	-1.11	H. Lundbeck A/S — Vyepti FDA Review (BLA761119, ORIG 1, 2020, p.50
Observed 50% responder rate for fourth quartile of AUC0-12wk (Weeks 1-12)	57	H Lundbeck A S — Vyepti EMA EPAR public assessment report (E, p.60
50% responder rate for placebo (Weeks 1-12)	39	H Lundbeck A S — Vyepti EMA EPAR public assessment report (E, p.60
Overall incidence of treatment-emergent ADA	15.9	H Lundbeck A S — Vyepti EMA EPAR public assessment report (E, p.52
Overall incidence of neutralizing antibody (NAb)	6.2	H Lundbeck A S — Vyepti EMA EPAR public assessment report (E, p.52
CHMP positive opinion date	11 November 2021	H Lundbeck A S — Vyepti EMA EPAR public assessment report (E, p.8
FDA Review Completion Date	1/31/2020	H. Lundbeck A/S — Vyepti FDA Review (BLA761119, ORIG 1, 2020, p.2

Source documents

Explore the full evidence

All 1298 cited findings for Vyepti — searchable, comparable and answerable in plain language — are in the Neurology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.