Hympavzi: genotox, carcinogenicity and repro: done or skipped?

“As a monoclonal antibody, genotoxicity assessment of marstacimab was not scientifically appropriate and therefore was not conducted.”

“Based on the WoE provided by the Applicant, the Division agreed that marstacimab is unlikely to pose a significant carcinogenicity safety concern for humans and therefore considered a 2-year study in rats unlikely to provide additional useful information.”

“The study identified no adverse effects at 1000 mg/kg/week (i.e., the no observed adverse effect level (NOAEL), which represented exposure >200-times the clinical exposure at the MRHD).”

“Intravenous administration of marstacimab at doses ranging from 30 to 500 mg/kg/week and SC administration of 90 mg/kg/week to monkeys had no effect on respiratory, neurological, or cardiovascular parameters.”