Emgality: which tox species, and why?

“The pivotal (GLP) subcutaneous (SC) toxicity studies (6-week + 9-week recovery, 3-month + 6-week recovery, and 6-month) were conducted in Sprague-Dawley rat and cynomolgus monkey.”

“Binding to monkey CGRP was not assessed because its sequence is identical to that of human CGRP; therefore, binding affinity was assumed to be similar in both species.”

“The pivotal (GLP) subcutaneous (SC) toxicity studies (6-week + 9-week recovery, 3-month + 6-week recovery, and 6-month) were conducted in Sprague-Dawley rat and cynomolgus monkey.”

“The pivotal (GLP) subcutaneous (SC) toxicity studies (6-week + 9-week recovery, 3-month + 6-week recovery, and 6-month) were conducted in Sprague-Dawley rat and cynomolgus monkey.”

“Studies in rats were conducted to assess the potential effects of galcanezumab on male and female fertility, embryo-fetal development (also in rabbits), and prenatal and postnatal development.”

“Carcinogenicity studies were not required, based on the potential for galcanezumab to counter CGRP associated angiogenesis and immunosuppression, specificity of galcanezumab for CGRP, lack of structural alerts on galcanezumab, and submitted toxicity and clinical studies, which indicated that galcanezumab has a low potential for carcinogenicity.”

“Galcanezumab is pharmacologically active in rat, rabbit, and human, as characterized in a series of binding and functional in vitro assays.”