A health ministry panel on Wednesday postponed a decision on whether to grant emergency approval to Shionogi’s COVID-19 pill, citing the need for more discussion.
The oral drug, which is the first domestically developed COVID-19 treatment and is intended for use in patients with light to moderate symptoms, had been up for evaluation by the panel after the Osaka-based pharmaceutical company applied for approval under the emergency authorization system created in May.
The panel, however, “could not reach a conclusion,” as its members were divided over several points including the efficacy of the drug, a health ministry official said after its closed meeting.
Shionogi’s clinical trial data had confirmed that the drug was effective in reducing the amount of the coronavirus in the body, but it failed to show an improvement in 12 symptoms in participants given the drug compared with those given a placebo.
The panel will meet again with another ministry committee in July before making a final decision, the ministry said.
During Wednesday’s meeting, a panel member questioned if the drug meets the emergency approval criteria that there is no other adequate drug available, a ministry official said. Shionogi’s pill, if approved, would be the third oral COVID-19 medicine in Japan after Merck’s molnupiravir and Pfizer’s Paxlovid.
There was also debate about the drug’s safety, with a member pointing to animal testing showing abnormalities in fetuses, according to the ministry. The pharmaceutical company does not recommend administering the drug to pregnant women.
The government has agreed to buy 1 million courses of the treatment immediately after its approval. Shionogi also has plans to further expand production to supply the drug to 10 million people globally each year.