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TOKYO (Jiji Press) — Abnormalities have been confirmed in some fetuses during animal tests for an oral COVID-19 drug developed by Shionogi & Co., which is pending regulatory approval, it has been learned.
Shionogi said data obtained from tests on animals suggest that the drug may not be recommended for use by pregnant women.
According to the company, teratogenic defects were confirmed in some fetuses during animal testing. The novel coronavirus pill has not been tested on expectant mothers during clinical trials.
While it is unknown what wording will be used to warn patients of the matter in the drug’s disclaimer, the wording will be decided by the government, with an official at Shionogi saying, “The phrases [on the warning label] will be decided during the drug review procedures, based on the data from animal testing.”
Shionogi has already reached a basic agreement with the government to supply the drug for 1 million people, based on the premise of the drug getting approved by the government.
The company is also planning to create by the end of fiscal 2022 a production system capable of manufacturing the drug for at least 10 million people every year.
