Japan COVID-19 Drug "Zokova" Approved: US$99 Per Treatment

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Japan COVID-19 Drug “Zokova” Approved: US$99 Per Treatment

Japan COVID-19 Drug “Zokova” Approved: US$99 Per Treatment.

Shionogi’s New COVID-19 Treatment Drug “Zokova” Granted Regular Approval by Ministry of Health, Labour and Welfare – First in Japan; Price to be Around 15,000 Yen 9 (about US$99) per Treatment from April

Shionogi & Co. announced that its oral drug “Zokova” for COVID-19 has received regular approval from the Japan Ministry of Health, Labour and Welfare, dated March 5th. This marks the first domestically approved COVID-19 treatment drug.

The COVID-19 treatment drug “Zokova,” developed by Shionogi, is an oral medication for mild to moderate cases, and it received emergency approval in November 2022.

Following that, on the 5th, Zokova was granted regular approval based on data from prescriptions to over a million people in Japan, confirming both its safety and effectiveness.

With the regular approval, it is no longer necessary to submit a patient consent form, which was previously required at the time of prescription.

The price of Zokova is 7,407 yen (about US$50) per tablet, with 7 tablets prescribed per treatment.

Regarding the self-payment amount for the treatment drug, for those responsible for 30% of the cost, the fixed amount per treatment will be 9,000 yen, but from April this year, it will be around 15,000 yen.

Shionogi stated, “We are pleased that the effectiveness and safety of Zokova have been recognized. We will continue to provide and collect data on its effectiveness and safety in the future.”

Japan COVID-19 Drug "Zicovar" Approved: US$99 Per Treatment. — Japan COVID-19 Drug “Zokova” Approved: US$99 Per Treatment(image screenshot from yahoojp)

Shionogi & Co., Ltd. has received regular approval in Japan for its COVID-19 therapeutic drug, ZicovarⓇ Tablets 125mg (generic name: Encitrelvir Fumarate), following emergency approval for “infections caused by SARS-CoV-2.” This approval is based on positive results from the Phase 2/3 SCORPIO-SR trial conducted in Japan, Korea, and Vietnam, demonstrating the drug’s effectiveness in treating a wide range of mild to moderate COVID-19 patients, including those with the Omicron variant. The trial showed ZicovarⓇ’s improvement effect on the 5 symptoms characteristic of COVID-19 and its antiviral effect, confirming its safety and effectiveness.

ZicovarⓇ was developed as a 3CL protease inhibitor through collaboration between Hokkaido University and Shionogi. The drug selectively inhibits the 3CL protease enzyme of the SARS-CoV-2 virus, thereby inhibiting its replication. In the Phase 3 part of the trial, ZicovarⓇ demonstrated its efficacy in improving symptoms and reducing viral load in COVID-19 patients. Since its emergency approval in November 2022, ZicovarⓇ has been used by over 1 million patients, contributing to the treatment of COVID-19.

Shionogi has identified “Liberation from the Threat of Infections” as a key focus area and is committed to advancing initiatives for comprehensive infection care. With the regular approval of ZicovarⓇ, Shionogi aims to provide a more reliable treatment option for COVID-19 patients in Japan, regardless of their risk factors for severe illness. The company also plans to accelerate global development efforts and gather more evidence to support the use of ZicovarⓇ in treating COVID-19 worldwide.

In addition to its approval in Japan, ZicovarⓇ has received import approval in Singapore based on SAR (Special Access Route) application, allowing its use in some facilities in Singapore since November 2023. Furthermore, the drug has received Fast Track designation from the U.S. Food and Drug Administration (FDA) to expedite its development and review process in the United States. Trials are ongoing globally, including the SCORPIO-HR trial targeting non-hospitalized SARS-CoV-2 infected patients, the STRIVE trial targeting hospitalized patients, the SCORPIO-PEP trial targeting household contacts, and a Phase 3 clinical trial targeting pediatric patients.

Shionogi and Medicines Patent Pool have also signed a licensing agreement to expand access to ZicovarⓇ in low- and middle-income countries (LMICs). Through these efforts, Shionogi aims to make ZicovarⓇ more widely available and contribute to the global fight against COVID-19.