Reporter Yoon So-young of Biospectator
3CL protease inhibitor ‘Xocova’, Japan’s first emergency use approval… Take a total of 7 tablets once a day for 5 days
Shionogi announced on the 22nd that it has received emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for ‘Xocova (ensitrelvir fumaric acid, S-217622)’ as a COVID-19 treatment.
Zocoba is a drug with a mechanism of inhibiting 3CL protease and is a drug taken orally in a total of 7 tablets once a day for 5 days.
Pfizer’s oral COVID-19 treatment ‘Paxlovid’ contains a total of 30 tablets, and MSD’s oral COVID-19 treatment ‘Molnupiravir’ contains a total of 40 capsules for 5 days. Because it is intended to be taken, Zocoba is easy to use compared to previously approved oral medications.
The approval makes Zokoba the first drug to be approved through Japan’s emergency use approval system. In May, Japan revised the Pharmaceutical and Medical Devices Act and established an emergency use approval system. In an emergency situation such as an infectious disease, if there is no substitute, even if clinical trials are not completed, if there is clinical data that can confirm the effectiveness and safety of the drug, it is a system that approves the market first . Drugs approved through this system can be marketed for approximately two years, and if additional efficacy and safety data are not submitted during this period, marketing is cancelled.
Shionogi pursued conditional approval based on phase 2b clinical trial results of Zokova in February, before the emergency use approval system was established. However, the strategy was changed to consent using the newly established emergency use approval in May, and this approval was decided after two approval decisions were suspended at the Pharmacy and Food Hygiene Council meeting in June and the month of July. Shionogi also submitted the front-line results of phase 3 clinical trials conducted with Zokoba to the regulatory body for approval.
This approval is based on the results of phase 2/3 clinical trials for patients with mild to moderate COVID-19 infection conducted by Zokova. Clinical results: Zokova significantly alleviated five major symptoms (stuffy or runny nose, sore throat, cough, fever, and fatigue) of Omicron-mutated COVID-19 infection and met the primary endpoint of the clinical trial. In terms of antiviral efficacy, Zocoba also significantly reduced viral RNA and met the secondary endpoint. Safety and tolerability were also good.
Shionogi CEO Teshirogi Isao said, “We are proud to have achieved meaningful results that can contribute to the recovery of COVID-19. We will try to provide new options,” he said.
Ildong Pharmaceutical is responsible for the domestic development of Zokoba. On the 23rd, Ildong Pharmaceutical said, “Through the contract with Ping Anshionogi (license holder), Ildong Pharmaceutical has obtained domestic licenses, production and sales rights, and plans to continue various activities such as the necessary preparations for obtaining domestic use approval.” published. .
