The health ministry on Nov. 22 sanctioned the use of an anti-COVID-19 drug manufactured by a domestic maker for the first time under the emergency regulatory approval system, with shipments expected to start early next month.
The oral drug Xocova marks the first home-grown medication, developed by Shionogi & Co., which can be prescribed for patients with mild symptoms, suggesting a stable supply of the tablet will be available.
The government has awarded the Osaka-based drugmaker a contract to buy the anti-viral agent for 1 million patients.
Xocova is reported to be effective in alleviating patients’ symptoms, such as fever, one day earlier than normal.
It also marked the first time the health ministry has fast-tracked a drug under the emergency approval system, which was established in May to speed authorities’ response to the infectious disease pandemic.
Xocova is thought to interfere with viral proliferation, if taken within three days after a patient displays symptoms.
It will be available to 12-year-olds or older with mild and moderate symptoms, regardless of their risks of developing serious illness.
The patient should take the tablet once daily for five days. The drug will be free as the treatment of patients infected with the novel coronavirus is currently financed by public funds.
Under the emergency approval system, a drug whose safety is confirmed can be endorsed for use if it “is presumed” to be effective in treating a contagious disease.
The system allows pharmaceutical companies to apply for emergency approval based on the results of clinical trials smaller in scale than usual processes involving thousands to tens of thousands of subjects.
In giving the nod to emergency use, the ministry also took into account the urgency of offering access to a medication, considering the rising COVID-19 cases in Japan.
Shionogi first requested a review of Xocova under a separate regulatory approval system in February.
But it switched to the emergency approval mechanism after its inauguration in May following the revision of the pharmaceuticals and medical devices law.
Although ministry’s reviews were conducted in June and July, authorities decided that they required additional testing of the drug.
That was because that Shionogi’s data on clinical trials involving about 400 subjects showed that it can reduce the amount of the virus, but its overall efficacy was not clear concerning 12 other symptoms, including fatigue and fever.
In September, Shionogi released a report on the results of additional clinical trials of about 1,800 subjects.
In the report, it said Xocova was found effective in alleviating five symptoms associated with an Omicron variant–runny nose, sore throat, coughing, fever and fatigue–in about seven days, one day earlier than those taking placebos.
But the company also said the tablet’s efficacy in preventing serious symptoms was not confirmed.
At a review meeting for emergency approval at the ministry on Nov. 22, a majority of officials agreed with the view that Xocova is presumed to be effective in treating COVID-19.
One official at the meeting was opposed to granting approval, citing the oral drugs by overseas pharmaceutical companies already available in Japan to treat the disease.
The approval will be valid for one year under the emergency regulatory approval system.
The ministry plans to conduct a fresh review of Xocova by asking the company to present further data on the drug.