Zycubo: which tox species, and why?

“A 13-week juvenile animal study in rats was conducted to evaluate the safety of CuHis and support administration of the product in a pediatric population.”

“A 13-week juvenile animal study in rats was conducted to evaluate the safety of CuHis and support administration of the product in a pediatric population.”

“Juvenile rats with normal baseline copper levels were administered CuHis in a 13-week subcutaneous toxicity and toxicokinetic study.”

“A 13-week juvenile animal study in rats was conducted to evaluate the safety of CuHis and support administration of the product in a pediatric population.”

“DART studies, including FEED, EFD, and PPND studies to evaluate the reproductive toxicity potential of CuHis in patients with MD can be waived as MD manifests predominantly in male infants.”

“Rodent carcinogenicity studies have not been conducted with CuHis. The limited life expectancy associated with classical MD is consistent with the International Council for Harmonisation S1A guidance criteria for waiving the requirement for carcinogenicity studies.”

“Juvenile rats with normal baseline copper levels were administered CuHis in a 13-week subcutaneous toxicity and toxicokinetic study.”