Ekterly: how long were the pivotal tox studies?

“the Applicant characterized the toxicity profile of sebetralstat with general toxicity studies in dogs (up to 4 weeks), and rats and monkeys (4 weeks, 13 weeks, and long-term dosing at durations up to 6 months).”

“To support the marketing authorisation, the applicant performed GLP-compliant repeat-dose studies in Crl:WI(Han) rats and in Cynomolgus NHP via oral route for up to 26 weeks.”

“In the 26-week study, NHP were also administered sebetralstat by oral gavage 0, 50, 100, 200 and 300 mg/kg/dose sebetralstat, twice weekly (Mondays and Fridays).”