Japan’s Health Ministry on Thursday granted fast-track approval for Pfizer’s oral COVID-19 drug, Paxlovid, to treat patients with mild symptoms amid the rapid spread of the coronavirus fueled by the Omicron variant in the country.
The ministry said in a
statement that it has secured 2 million courses of treatment with the U.S.-based drugmaker Pfizer, of which 40,000 pills have already been imported in advance. The remaining courses of treatment will be delivered in late February.
It stated (
pdf) that pills distribution will begin on Monday, with just 2,000 medical institutions nationwide permitted to prescribe Paxlovid in-hospital until at least Feb. 27, due to concerns over the pill’s compatibility with other kinds of drugs.
Paxlovid is a combination of two antiviral drugs–nilmatrelvir, which blocks the virus from replicating, and ritonavir–which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period of time. The pill is prescribed to be taken twice a day for five days.
According to Pfizer Japan’s
statement, the drug is to be used for people age 12 and older, who weigh at least 40 kilograms (88 pounds) and are at high risk for progression to severe infection, including hospitalization.
The U.S. Food and Drug Administration (FDA) had also
granted an emergency use of authorization for Paxlovid last December for patients with mild-to-moderate symptoms, with the pill available only by prescription.
FDA said the pill “significantly reduced” the proportion of infected patients at risk of severe symptoms from any cause by 88 percent, compared to placebo among patients within five days of symptom onset and who did not get COVID-19 therapeutic monoclonal antibody treatment.
Pfizer’s Paxlovid is the second oral antiviral pill approved by Japan after Merck & Co.’s molnupiravir.
The Japanese government
secured 1.6 million courses of molnupiravir in December last year to accelerate treatment access for patients, following the increasing number of COVID-19 infections in the country.
Japan reported 99,694 new COVID-19 cases on Thursday, with government officials attributing the increase to Omicron infections in the country.
Prime Minister Fumio Kishida on Wednesday extended the quasi-emergency measures for Tokyo and 12 prefectures from the
initial deadline of Feb. 13 to Mar. 6 to contain the spread of the virus.
“We are consulting [with the government panel] to extend the measure because the situation is far from safe to lower the guard,” Kishida told reporters, local media Kyodo News
reported.
Under the quasi-emergency measures, governors are allowed to shorten business hours and limit the serving of alcohol in the selected prefectures.
