Japanese pharmaceutical company (Shionogi) has announced that its 125-m g tablet Xocova (ensitrelvir fumaric acid: S-217622) has been approved by emergency supervision of the Ministry of Health and Welfare (MHLW) for the treatment of novel Coronavirus (SARS-CoV-2) infection. The approval was granted through the emergency regulatory approval system provided under section 14-2-2 of the Medicines and Medical Devices Act. According to the Xocova domestic supply basic agreement signed by Yanano and MHLW in March 2022, the Japanese government and MHLW for the purchase of 1 million courses of Xocova is now in effect.
Xocova is an oral antiviral drug, administered over a once-daily 5-day treatment course for the treatment of COVID-19 (COVID-19). Xocova is a 3CL protease inhibitor developed by Hokkaido University together with Keno. The 3-3CL protease is essential for the replication of the novel coronavirus (SARS-CoV-2).ensitrelvir inhibits the replication of the novel coronavirus by selectively inhibiting the 3CL protease.
Based on the results obtained in phase 2b of the Phase 2 / 3 clinical trial, Iyano applied for production and sales in Japan on 25 February 2022 for review under the Conditional Approval System. On May 27, Yano resubmitted its application for a review under the new "emergency supervision and approval system", as amended by the Drugs and Medical Devices Act. On July 20th, the Japan Pharmaceutical Affairs and Food Health Board meeting considered the Xocova emergency approval and continued its review based on the results of the phase 3 study submitted by Kenino, which confirmed that the study reached the primary endpoint.
It is worth mentioning that Xocova is the first drug approved under the new emergency approval system in Japan. Dr. Isao Teshirogi, CEO of Yanano, said: " We are proud to take this milestone as we are starting to contribute to public recovery from SARS-CoV-2 infection. She will continue to work hard to provide new options for the treatment of SARS-CoV-2 infection, not only in Japan, but also throughout the world, including low-and middle-income countries (LMIC).”
Harshino will continue to pursue full Xocova approval and continue to seek global registration, including a partnership with Medicines Patent Pool (Pharmaceutical Patent Pool), to provide LMIC access, and to expand and strengthen it's manufacturing and global supply chain.
