Synagis: which tox species, and why?

“These results could be confirmed in Cynomolgus monkeys after a single administration of palivizumab.”

“The lack of repeated dose toxicity studies (including reproductive toxicity) was justified by the company by the immunogenicity of the human compound in animals and the lack of binding of the compound to a range of tissues.”

“A single dose toxicity study of palivizumab administered to Sprague Dawley rats via intravenous injection including assessment of clinical signs, body weight changes, food consumption, ophthalmoscopy, haematology, clinical and anatomic pathology until 14 days post injection”

“The lack of repeated dose toxicity studies (including reproductive toxicity) was justified by the company by the immunogenicity of the human compound in animals and the lack of binding of the compound to a range of tissues.”

“The applicant stated in the preclinical expert report that since the product is indicated only for use in infants there is no need to evaluate the potential toxicity of palivizumab on the reproduction.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“These results could be confirmed in Cynomolgus monkeys after a single administration of palivizumab.”