Osaka-based pharmaceutical and medical device developer and manufacturer Shionogi & Co. Ltd. (SGIOY:OTC-US; 4507:TYO) announced yesterday that Japan's Ministry of Health, Labor and Welfare (MHLW) had granted emergency regulatory approval for its novel anti-SARS-CoV-2 drug, Xocova® (ensitrelvir fumaric acid), for use in the treatment of infection from COVID-19.
The company stated that the authorization for Xocova® 125mg tablets was issued under the special emergency approval provisions of Japan's Pharmaceuticals and Medical Devices Act. The firm advised that in March 2022, it signed a supply agreement with the MHLW, and now that Xocova® has been granted approval the contract to provide the Japanese government with one million courses of Xocova® for domestic uses is now fully effective.
Shionogi indicated that "Xocova® is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease." The firm noted that at present, Xocova® (ensitrelvir) is still classified as an unapproved, investigational drug outside of Japan.
According to the report, Shionogi submitted an application via MHLW's established conditional approval system near the end of February 2022 to manufacture and market Xocova® based on data collected in Phase 2b, part of a Phase 2/3 clinical trial.
The company commented that with the action taken yesterday, Xocova® has gained the distinction of becoming "the first drug approved under the new emergency approval system."
The company refiled the application on May 27, 2022, with the Pharmaceuticals and Medical Devices Agency (PMDA) to request emergency regulatory approval.
The company commented that with the action taken yesterday, Xocova® has gained the distinction of becoming "the first drug approved under the new emergency approval system."
Shionogi & Co.'s CEO Isao Teshirogi, Ph.D., remarked, "We are proud to reach this landmark step which marks the start of our real contribution to people's recovery from SARS-CoV-2 infection. Shionogi will continue to work intensively to deliver this new option for treating SARS-CoV-2 infected patients not only in Japan but also throughout the world, including in low- and middle-income countries."
The company advised that it has been working closely with the MHLW to facilitate prompt and effective distribution of Xocova® to medical institutions in Japan. The firm intends to commence shipping immediately to authorized pharmaceutical wholesalers and registered prescribing medical institutions.
Shionogi advised that Xocova® received approval based on results gathered from 497 individuals in its Phase 2 trial and 1,821 people in the Phase 3 portion of the study.
The company highlighted that "Xocova® is the first antiviral agent to show both symptomatic clinical efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, during the Omicron-dominant phase of the epidemic."
Going forward, Shionogi plans to proceed in its efforts to secure standard approval for Xocova® for general distribution both inside and outside of Japan.
The company stated that Xocova® (ensitrelvir fumaric acid) is an antiviral drug that has been developed to treat infection from COVID-19. The firm explained that Xocova is a 3CL protease inhibitor that was created and developed through a research collaboration between Shionogi and Hokkaido University. The report mentioned that Xocova® works by selectively inhibiting and suppressing 3CL protease enzymes in SARS-CoV-2, which prevents the virus from replicating itself.
Xocova is currently being evaluated in Phase 2b/3 clinical trials that are being conducted mostly in Japan as well as on a smaller scale in other Asian countries. The focus of these studies is limited to SARS-CoV-2-infected individuals with mild or asymptomatic symptoms only. During studies conducted to date, ensitrelvir has been shown to be safe and well tolerated, and no treatment-related serious adverse events or deaths have occurred.
The firm stated that it is currently conducting its global Phase 3 SCORPIO-HR study in non-hospitalized SARS-CoV-2 infected patients and plans to initiate a separate global Phase 3 trial focused on hospitalized SARS-CoV-2 infected patients very soon. In addition, two other studies are now being planned to address prevention for household members who are living with SARS-CoV-2 infected persons and a pediatric study in children under twelve years of age.
Shionogi & Co. Ltd. is a pharmaceutical firm headquartered in Osaka, Japan, that is best known for developing the cholesterol drug CRESTOR® (rosuvastatin calcium), which it licenses to AstraZeneca Plc. (AZN:NYSE; AZN:LON). The company is engaged in the research, development, manufacture, marketing, and distribution of medicines, diagnostic reagents, and medical devices used to treat infectious diseases and other serious unmet medical needs.
The firm stated that it is currently focused on developing therapeutics that address all areas of the infectious disease care ecosphere, from education and prevention to epidemiologic monitoring, diagnosis, mitigation, and treatment of the infection itself. The company indicated that it remains committed to new products and services to address the SARS-CoV-2 pandemic.
Shionogi & Co. has a market cap of around US$14.82 billion, with approximately 1.23 billion shares outstanding. SGIOY U.S. ADR shares opened more than 13% higher yesterday at US$13.90 (+US$1.65, +13.47%) over Monday's US$12.25 closing price. The stock traded yesterday between US$13.45 and US$14.13 per share and closed for trading at US$13.80 (+US$1.55, +12.65%).
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