By KANAKO TANAKA/ Staff Writer
April 13, 2022 at 14:41 JST
Oral COVID-19 pills developed by Shionogi & Co. (Provided by Shionogi & Co.)
Shionogi & Co.'s oral COVID-19 pill in development will likely not be recommended for pregnant women due to abnormalities detected in animal testing, the company said April 12.
The Osaka-based drug company requested approval in February from the health ministry for the practical use of the pill.
If the drug is put into practical use, however, it will not be recommended for use by pregnant women.
Shionogi said it conducted animal testing before the start of clinical trials.
Teratogenesis occurred when a high concentration of the drug was administered to pregnant rabbits.
It produced abnormalities in a fetus's skeletal development.
“We don’t think the drug will be recommended to pregnant women, but it will ultimately be decided by the reviewing authority,” said a representative of the company.
Shionogi filed an application on Feb. 25 for health ministry approval for manufacturing and selling its oral COVID-19 pill--the first domestic drug company to do so.
The ministry has reviewed the application.
The government has approved oral COVID-19 pills by Pfizer and Merck, both U.S. companies, for COVID-19 patients with mild symptoms.
However, the ministry has banned the use of Merck’s Lagevrio for pregnant women after there were cases of teratogenesis.
The ministry has allowed the use of Pfizer’s Paxlovid Pack for pregnant women only when the merit of treatment exceeds the risk.
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