TOKYO: Japanese health minister Shigeyuki Goto gave approval on Thursday to an oral COVID-19 remedy developed by US drugmaker Pfizer Inc.
The fast-track approval of Paxlovid was issued after a subcommittee of the Pharmaceutical Affairs and Food Sanitation Council, an advisory panel to the health minister, supported the approval plan at a meeting the same day.
It is the second oral drug against the novel coronavirus to be approved in Japan, following Merck & Co.’s molnupiravir.
The Pfizer remedy is said to reduce risks of developing severe symptoms by 90 pct and be effective against the highly transmissible omicron variant.
The government hopes to make the drug widely available by the end of this month. It hopes to relieve the burden on the medical system by securing multiple widely available oral drugs.
Paxlovid will be delivered to medical institutions, beginning on Monday.
According to the health ministry, the Pfizer oral drug is designed for COVID-19 patients with mild or moderate symptoms who are at risk of becoming seriously ill among adults as well as minors aged 12 or older who weigh at least 40 kilograms. The drug should be administered twice daily for five days.
Special care is needed for prescription as Paxlovid cannot be administered concurrently with about 40 medicines, including those to tackle elevated blood pressure and insomnia. The drug package insert calls for checks on all medicines used by the patient before Paxlovid is prescribed.
After some members of the subcommittee stressed the need for prudence in administering the drug, the ministry will limit its use to in-hospital prescription at about 2,000 medical institutions until Feb. 27.
Like molnupiravir, Paxlovid is an antiviral, meaning that it prevents the increase of the virus. It consists of two types of medicine.
Paxlovid was given emergency approval in the United States last December, and was given a recommendation for approval in the European Union last month.
Pfizer applied for approval in Japan in January.
In clinical trials targeting coronavirus patients with risks of severe symptoms, hospitalization and death risks decreased by 89 pct when the drug was taken within three days of developing symptoms and 88 pct when it was taken within five days.
It is thought to be more effective than molnupiravir, which reduces such risks by around 30 pct.
Japan has reached a final agreement with Pfizer to buy Paxlovid doses for two million people by the end of this year, of which doses for about 40,000 people will be delivered soon.