TOKYO, Nov 22 (Reuters) – Japan on Friday said it would grant emergency approval to Japanese drugmaker Shionogi & Co Ltd’s (4507.T) COVID-19 drug, making it the first domestically developed oral drug for patients with mild symptoms.
Regulators in Japan had previously denied emergency approval for the Shionogi pill, saying they wanted to see more data on its effectiveness. There were also concerns the drug could pose risk to pregnancies, based on results from animal studies.
Health Minister Katsunobu Kato announced the decision on the oral drug, known as Ensitrelvir, after approval was granted by a health ministry panel.
“I expect it will contribute to coronavirus measures as another choice of treatment,” Kato told reporters, although he said its use would not be allowed in the case of pregnant women.
Despite the delay in approving the treatment, Shionogi last month raised its full-year sales forecast on expectations it would win regulatory approval.
The company has signed an agreement to sell about a million doses to the government, pending the drug’s approval.
Shionogi shares closed up 2.77% at 7,171.0 after a morning media report that approval was near.
Reporting by Mariko Katsumura, Kaori Kaneko and Elaine Lies; Editing by Kenneth Maxwell, Kirsten Donovan
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