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The Ministry of Health on November 22 approved the use of an anti-COVID-19 drug produced by a domestic manufacturer for the first time, and shipments are expected to begin early next month.
Xocova Oral Drug Shionogi & Co. developed by marks the first home-grown drug that can be prescribed for patients with mild symptoms, suggesting a sustained supply of the tablet.
The government has awarded an Osaka-based drugmaker a contract to buy an antiviral agent for 1 million patients.
Xocova has been reported to be effective in reducing patients’ symptoms, such as fever, a day earlier than normal.
It also marked the first time the health ministry had fast-tracked a drug under an emergency approval system set up in May to speed up authorities’ response to the pandemic.
Xocova is thought to prevent the virus from spreading if taken within three days of the patient showing symptoms.
It is available to those 12 years of age or older with mild to moderate symptoms regardless of their risk of serious illness.
The patient should take the pill once a day for five days. The medicine will be free, as the treatment of patients infected with the new type of coronavirus is currently financed by the state.
Under the emergency system, a drug with proven safety can be approved for use if it is “presumed” to be effective in treating an infectious disease.
The system allows pharmaceutical companies to apply for expedited approval based on the results of clinical trials that are smaller in scale than conventional processes involving thousands to tens of thousands of subjects.
Subject to emergency use, the ministry also noted the urgency of offering access to the medicine in light of the rising number of COVID-19 cases in Japan.
Shionogi first requested a review of Xocova in February under a separate regulatory approval system.
But he moved to an emergency approval mechanism after revising the Pharmaceuticals and Medical Devices Act after his inauguration in May.
Although the ministry’s inspections were carried out in June and July, the authorities asked them to carry out additional tests on the drug.
That’s because Shionogi’s data from clinical trials involving nearly 400 subjects showed it could reduce viral load, but its overall effectiveness on 12 other symptoms, including fatigue and fever, was unclear.
In September, Shionogi published a report on additional clinical trials involving nearly 1,800 subjects.
The report found that five symptoms associated with the Xocova Omicron variant – runny nose, sore throat, cough, fever and fatigue – were found to be effective within seven days, one day earlier than those taking placebo.
But the company also said the tablet’s effectiveness in preventing serious symptoms has not been confirmed.
At a review conference held for emergency approval at the ministry on November 22, the majority of officials agreed that Xocova would be effective in treating COVID-19.
An assembly official objected to the approval, citing oral drugs from foreign pharmaceutical companies available in Japan to treat the disease.
The approval is valid for one year under the emergency regulatory approval system.
The ministry has asked the company to provide additional information on the drug and plans to conduct a new review of Xocova.
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