Shionogi’s Investigational COVID-19 Drug Linked to Fetal Abnormalities

Shionogi’s Investigational COVID-19 Drug Linked to Fetal Abnormalities

Shionogi has confirmed reports that its investigational COVID-19 drug, S-217622, led to fetal abnormalities in a preclinical study.

The study of the 3CL protease inhibitor in animal subjects, which used higher doses of the drug than is planned for humans, found that it led to fetal abnormalities when given to pregnant animals.

The company said it reported the results to Japan’s Pharmaceuticals and Medical Devices Agency in December 2021 and that it doesn’t believe they will adversely affect the agency’s regulatory decision.

Among other clinical studies, Shionogi is launching a phase 3 U.S. trial with 1,729 participants to compare S-217622 with placebo in nonhospitalized, high-risk participants with COVID-19.

April 14, 2022

https://www.fdanews.com/


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