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By Peter Lander


TOKYO — A panel from Japan’s Ministry of Health, Labor and Welfare ruled on Wednesday that a Shionogi & Co. pill to treat Covid-19 was not ready for emergency approval, citing a lack of data effectiveness and the availability of alternatives from Pfizer Inc. and Merck & Co.

The panel was unanimous in deciding that approval should await data from a larger human trial of the drug Shionogi, codenamed S-217622. The data should be available by November, said experts at the Wednesday evening meeting in Tokyo.

The drug Shionogi inhibits an enzyme that the virus known as SARS-CoV-2 needs to replicate. It has a mechanism similar to Pfizer’s drug Paxlovid, which is already marketed in many countries, including the United States and Japan.

Experts who spoke at the meeting said it would be helpful for doctors to have an alternative pill in addition to Merck’s Paxlovid and Lagevrio, but observed that Shionogi’s data so far , while showing that the drug has a strong antiviral effect, does not demonstrate that it would help patients recover faster.

Yamanashi University President Shinji Shimada told the meeting that the first priority in the fight against the latest wave of Covid-19 should be to promote greater use of Paxlovid. Government data presented at the meeting showed Paxlovid had been prescribed for only 14,200 patients in Japan as of Tuesday, compared to 235,900 prescriptions for Lagevrio.

“I really think it’s a problem that this drug isn’t being used to the fullest,” Dr. Shimada said of Paxlovid.

Shionogi filed in February for emergency approval of S-217622 in Japan.


Write to Peter Landers at [email protected]