“Secukinumab crossreacts with cynomolgus, rhesus and marmoset monkey IL-17A, but not with rodent IL-17A, making the cynomolgus monkey the most appropriate nonclinical species.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Why that species
Cross-reacts with cynomolgus, rhesus and marmoset IL-17A but not rodent IL-17A
“Secukinumab crossreacts with cynomolgus, rhesus and marmoset monkey IL-17A, but not with rodent IL-17A, making the cynomolgus monkey the most appropriate nonclinical species.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Surrogate molecule
Yes: murine anti-mouse IL-17A antibody BZN035, used for mouse fertility/early embryonic and peri-/postnatal development studies
“A murine surrogate antibody against mouse IL-17A (BZN035) was developed and used for fertility and early embryonic development and peri- and postnatal development studies in mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Species: general tox
Cynomolgus monkey only
“Secukinumab crossreacts with cynomolgus, rhesus and marmoset monkey IL-17A, but not with rodent IL-17A, making the cynomolgus monkey the most appropriate nonclinical species.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
“Single-dose and repeat-dose toxicity and embryofetal development studies have been conducted with the cynomolgus monkey. A murine surrogate antibody against mouse IL-17A (BZN035) was developed and used for fertility and early embryonic development and peri- and postnatal development studies in mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Species: carcinogenicity
Not conducted
“No genetic toxicity or carcinogenicity studies have been conducted with secukinumab.”
✓ VerifiedFDA pharmacology/toxicology review, p. 33Source ↗
Surrogate used in
Yes: mouse surrogate anti-mouse IL-17A antibody (BZN035) for fertility/early embryonic and pre/postnatal development studies
“A murine surrogate antibody against mouse IL-17A (BZN035) was developed and used for fertility and early embryonic development and peri- and postnatal development studies in mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗