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

“Fosdenopterin was without genotoxic potential in vitro and in vivo in the standard battery of tests indicated in ICH S2(R1).”

“Carcinogenicity studies with fosdenopterin have not been conducted. A carcinogenicity study in a single species will be conducted as a postmarketing requirement.”

“Nonclinical reproductive and developmental toxicity studies with fosdenopterin have not been conducted. These studies will be conducted as a postmarketing requirement.”

“No fosdenopterin-related effects were observed in vitro or on cardiovascular, CNS or respiratory parameters in vivo. Due to low maximum dose levels, margins at no-observed-effect-level (NOEL) are low to non-existing.”

“Fosdenopterin was not genotoxic in a standard battery of in vitro (bacterial reverse mutation and human lymphocyte chromosomal aberration) and in vivo (rodent bone marrow micronucleus) assays.”

“Fosdenopterin was not genotoxic in a standard battery of in vitro (bacterial reverse mutation and human lymphocyte chromosomal aberration) and in vivo (rodent bone marrow micronucleus) assays.”

“Fosdenopterin was not genotoxic in a standard battery of in vitro (bacterial reverse mutation and human lymphocyte chromosomal aberration) and in vivo (rodent bone marrow micronucleus) assays.”

“Carcinogenicity studies with fosdenopterin have not been conducted. A carcinogenicity study in a single species will be conducted as a postmarketing requirement.”

“A two-year carcinogenicity study in mice is however planned as a post-marketing requirement from FDA.”

“In an automated screening assay for a number of ion channels (study 190129.PSN), there were no effects of fosdenopterin on the hERG current at concentrations up to 300 µM.”