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Tysabri: how long were the pivotal tox studies?

natalizumab · α4-integrin
Longest pivotal study
26 weeks
“Chronic toxicity studies of repeated doses of natalizumab over a 26-week period, followed by a 17 week dose-free period in cynomolgus monkeys”
✓ VerifiedEMA assessment report, p. 10Source ↗
Pivotal GLP studies
Weekly IV infusion for six months in adult and juvenile cynomolgus monkeys; shorter alternate-day IV monkey studies; rhesus combination study with Avonex
“A six-month toxicity study with natalizumab as weekly intravenous infusion in juvenile cynomologus monkeys with a 17-week recovery period”
✓ VerifiedEMA assessment report, p. 10Source ↗
Route in tox
IV
“In several repeated dose toxicity studies in cynomolgus monkeys the dosing of 3, 10, or 30 mg/kg of natalizumab was performed on alternate days through day 28 by IV injection.”
✓ VerifiedEMA assessment report, p. 9Source ↗

Same question, other monoclonal antibodies

Actemra

tocilizumab · IL-6R
26 weeks

Adakveo

crizanlizumab · P-selectin
26 weeks

Adbry

tralokinumab · IL-13
26 weeks

Aduhelm

aducanumab · Aggregated amyloid-β
26 weeks

Aimovig

erenumab · CGRP receptor
26 weeks

Ajovy

fremanezumab · CGRP
26 weeks

Alhemo

concizumab · TFPI
52 weeks

Andembry

garadacimab · Factor XIIa
26 weeks

Anthim

obiltoxaximab · B. anthracis PA
1 (dosing on Days 1, 4 and 7 in rats)

Arzerra

ofatumumab · CD20
30 (7 months)

Avastin

bevacizumab · VEGF-A
26 weeks

Benlysta

belimumab · BLyS (BAFF)
26 weeks

Bimzelx

bimekizumab · IL-17A/IL-17F
26 weeks

Cablivi

caplacizumab · von Willebrand factor (A1 domain)
26 weeks

Cimzia

certolizumab pegol · TNF-α
52 weeks

Cyramza

ramucirumab · VEGFR2
39 weeks

Ebanga

ansuvimab · Zaire ebolavirus glycoprotein
4 weeks

Ebglyss

lebrikizumab · IL-13
39 weeks

Empliciti

elotuzumab · SLAMF7
0 (no repeat-dose toxicity studies)

Enflonsia

clesrovimab · RSV F protein (site IV)
2 weeks

Enjaymo

sutimlimab · Complement C1s
26 weeks

Entyvio

vedolizumab · α4β7-integrin
26 weeks

Evenity

romosozumab · Sclerostin
26 weeks

Evkeeza

evinacumab · ANGPTL3
26 weeks

Fasenra

benralizumab · IL-5Rα
39 weeks

Gazyva

obinutuzumab · CD20
26 weeks

Humira

adalimumab · TNF-α
39 weeks

Ilaris

canakinumab · IL-1β
26 weeks

Ilumya

tildrakizumab · IL-23 p19
39 weeks

Imaavy

nipocalimab · FcRn
26 weeks

Imjudo

tremelimumab · CTLA-4
26 weeks

Kisunla

donanemab · Amyloid-β (N3pG)
22 weeks

Leqembi

lecanemab · Amyloid-β protofibrils
39 weeks

Nucala

mepolizumab · IL-5
26 weeks

Omvoh

mirikizumab · IL-23 p19
26 weeks

Opdivo

nivolumab · PD-1
13 weeks

Pasatru

garetosmab · Activin A
26 weeks

Piasky

crovalimab · Complement C5
26 weeks

Praxbind

idarucizumab · Dabigatran
4 weeks

Prolia

denosumab · RANKL
52 weeks

Raxibacumab

raxibacumab · B. anthracis protective antigen
3 weeks

Remicade

infliximab · TNF-α
26 (mouse surrogate antibody)

Siliq

brodalumab · IL-17RA
26 weeks

Simulect

basiliximab · IL-2Rα (CD25)
4 weeks

Skyrizi

risankizumab · IL-23 p19
26 weeks

Soliris

eculizumab · Complement C5
26 weeks

Spevigo

spesolimab · IL-36R
26 weeks

Stelara

ustekinumab · IL-12/23 p40
26 weeks

Synagis

palivizumab · RSV F protein
0 (no repeat-dose studies; single-dose only)

Takhzyro

lanadelumab · Plasma kallikrein
26 weeks

Taltz

ixekizumab · IL-17A
39 weeks

Tepezza

teprotumumab · IGF-1R
39 weeks

Tremfya

guselkumab · IL-23 p19
24 weeks

Tzield

teplizumab · CD3
1 weeks

Ultomiris

ravulizumab · Complement C5
26 weeks

Uplizna

inebilizumab · CD19
26 weeks

Veopoz

pozelimab · Complement C5
26 weeks

Voyxact

sibeprenlimab · APRIL
26 weeks

Vyepti

eptinezumab · CGRP
26 weeks

Vyloy

zolbetuximab · Claudin 18.2
13 weeks

Xolair

omalizumab · IgE
26 weeks

Yervoy

ipilimumab · CTLA-4
26 weeks

Zinbryta

daclizumab · IL-2Rα (CD25)
39 weeks

Zinplava

bezlotoxumab · C. difficile toxin B
3 weeks

Zynyz

retifanlimab · PD-1
13 weeks

Beovu

brolucizumab · VEGF-A
Not stated in public reviews

Summary across all 117 monoclonal antibodies →