Vyepti (eptinezumab): animal efficacy model or human cells?

Atlas/Monoclonal antibodies/Vyepti/Efficacy evidence

Vyepti: animal efficacy model or human cells?

eptinezumab · CGRP

Efficacy evidence

Capsaicin- or CGRP-induced dermal blood flow increase in rats, cynomolgus monkeys and rabbits

“In vivo activity of eptinezumab was demonstrated in a model of capsaicin-induced increase in dermal blood flow in rats and cynomolgus monkeys and a model of vasodilation induced intradermal injection of CRGP in rabbits.”

✓ VerifiedEMA assessment report, p. 27Source ↗

Why that model

No animal models of migraine exist; therapeutic evidence comes from clinical data

“There are no animal models for migraine; thus, the evidence for a therapeutic effect are derived from the clinical data.”

✓ VerifiedEMA assessment report, p. 27Source ↗

Reviewer's view of the efficacy data

FDA: high affinity for alpha- and beta-CGRP and effective antagonism of CGRP activity shown

“In conclusion, eptinezumab was shown to have high affinity for α- and β-CGRP and to effectively antagonize CGRP activity.”

✓ VerifiedFDA pharmacology/toxicology review, p. 44Source ↗

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ixekizumab · IL-17A

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atezolizumab · PD-L1

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Ultomiris

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cosibelimab · PD-L1

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inebilizumab · CD19

EAE and Sle1 autoimmune models in huCD19 transgenic mice: B-cell depletion, reduced autoantibodies and disease scores

Vectibix

panitumumab · EGFR

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pozelimab · Complement C5

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Voyxact

sibeprenlimab · APRIL

gddY IgA nephropathy mouse model with mouse surrogate mAb 4540; IgA reduction in healthy monkeys with sibeprenlimab

Vyloy

zolbetuximab · Claudin 18.2

Mouse xenograft models of human gastric cancer

Xolair

omalizumab · IgE

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Yartemlea

narsoplimab · MASP-2

In vivo mouse model of TMA and ex vivo aHUS patient serum on human endothelial cells

Yervoy

ipilimumab · CTLA-4

MC-38 colon carcinoma in human CTLA-4 transgenic mice

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daclizumab · IL-2Rα (CD25)

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Zinplava

bezlotoxumab · C. difficile toxin B

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retifanlimab · PD-1

Retifanlimab binding to peripheral T cells (flow cytometry) in cynomolgus monkey studies

Summary across all 117 monoclonal antibodies →