Omvoh: which risks did reviewers probe?

“In both six-month studies immunophenotyping, T-dependent antibody responses and NK cell cytotoxicity was assessed without any significant effect of mirikizumab on the parameters measured.”

“Furthermore, a tissue cross-reactivity study performed with human and cynomolgus monkey tissues (see toxicology section) did not identify any specific mirikizumab staining suggesting a low potential for off-target binding and pharmacological effects.”

“No evidence of increased cellular proliferation or effects on immunosurveillance (circulating lymphocytes, natural killer cell function, primary immune response, lymphoid organ histopathology) have been observed in repeat dose toxicity studies in cynomolgus monkeys”

“ADAs were measured in this study with 7 animals (4 at 100 mg/kg, 3 at 300 mg/kg) testing positive for ADAs. Exposure at Day 176 was lower in one ADA-positive female, however, other ADA-positive animals did not exhibit any significant reduction in serum mirikizumab levels.”

“During the 52-week treatment period in studies UC-1 and UC-2, 23% (88/378) of OMVOH-treated subjects at the recommended dosage and evaluable for assessment, developed anti-mirikizumab-mrkz antibodies (referred to as anti-drug antibodies (ADA)).”