The approval of the oral treatment for COVID-19 arrives in Japan not long after the country reopened its borders to tourists again. At the same time, cases have been growing steadily, leading some to dub the rise an ‘eighth wave’.
Within this environment, the Japanese government, through the Ministry of Health, Labour and Welfare (MHLW), provided emergency regulatory approval for Shionogi’s Xocova (ensitrelvir fumaric acid) as a treatment for SARS-CoV-2 infection.
The Japanese government also committed to purchasing one million doses of Xocova, through an agreement signed by Shionogi and MHLW in March 2022.
According to the Japanese company, it will begin distribution of the treatment immediately to pharmaceutical wholesalers and is accepting orders from suitable registered medical institutions and pharmacies.
The treatment is an oral antiviral agent that is administered once daily for five days, which suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Shionogi was able to use Phase III results showing that the treatment had met its primary endpoint, allowing it to become the first treatment to be approved under Japan’s new emergency approval system.
The company stated that the review for full approval by the Pharmaceuticals and Medical Devices Agency is ongoing.
Previously, the oral treatment had been knocked back by Japanese authorities for emergency approval, as they awaited further trial data.
“Shionogi will continue to work intensively to deliver this new option for the treatment of SARS-CoV-2 infected patients not only in Japan but also throughout the world, including in low- and middle-income countries (LMICs),” said Isao Teshirogi, CEO of Shionogi.
Shionogi outlined that it is currently working with the Medicines Patent Pool to provide access to LMICs. The company is also working on expanding its manufacturing capacity for the treatment, as well as strengthening its global supply chain.
This action follows on from backlash that has emerged against companies that have profited from similar oral treatment, such as Pfizer and Gilead. The former company announced in October 2022 that it would make six million oral treatments available to lower-income countries.
Vaccine edging towards approval
Only a few days after the emergency approval for its oral COVID-19 treatment, Shionogi announced that it had filed with Japanese authorities for approval of its recombinant protein-based vaccine against COVID-19.
The filing is based on five clinical trials conducted in Japan. The company is looking at delivering the treatment as a multi-dose vaccine, similar to other available vaccines, where a primer is delivered and is followed up by booster doses.
Though the approval for the vaccine would emerge later than other vaccines, it would represent the first Japanese-made vaccine to enter the market.