Update: Japan Approves Remdesivir For Use On Severe COVID-19 Patients
Japan approved the antiviral drug Remdesivir of the Gilead Sciences for the treatment of severe COVID-19 patients, making itself and the United States are the only two countries who have authorized use of remdesivir for the treatment of COVID-19.
The approval is under an exceptional approval
pathway based on clinical data of phase III trial from the U.S. National Institute of
Allergy and Infectious Diseases, referencing the United States’ Emergency Use Authorization of the drug to treat severe cases of COVID-19.
The infection of a novel coronavirus (2019-nCoV) found in Wuhan, Hubei Province, a city of 11 million people in central China has been spreading rapidly, and the incidence rate is increasing worldwide. The COVID-19 virus can cause serious complications include pneumonia, severe acute respiratory syndrome, kidney failure, and even death in the most severe cases. As of February 17, 2020, there were 70532 confirmed cases in China, 8228 suspected cases, and 1767 deaths. There were confirmed cases reported in 34 provincial administrative regions in China; 25 foreign countries reported new coronavirus pneumonia cases, 691 confirmed cases, and 3 deaths. The reported number of infected patients far exceeding the total number of the 2003 SARS epidemic (37 countries, 8,098 cases and 774 deaths).
On February 11, 2020, the World Health Organization (WHO) announced an official name COVID-19 for the disease that is causing the 2019 novel coronavirus outbreak in Wuhan, China. Since this outbreak first emerged, the US FDA and CDC are closely monitoring an outbreak of respiratory illness caused by the COVID-19 pathogen emerged in China and worldwide.
What is the 2019-novel coronavirus (COVID-19)?
There are hundreds of coronaviruses, some causing illness in people and others that circulate among animals including pigs, camels, civets, cats and bats. But occasionally a coronavirus mutates and can pass from animals to humans and then from human to human. However, three of the coronaviruses can have more serious outcomes in people, and those are severe Acute Respiratory Syndrome (SARS) which emerged in late 2002 and disappeared by 2004; Middle East Respiratory Syndrome (MERS), which emerged in 2012 and remains in circulation in camels; and the 2019 novel coronavirus, or known as COVID-19, which contains SARS-CoV and MERS-CoV, the genetic analyses suggest COVID-19 can cause severe respiratory illness in humans, but, there is currently no effective treatment options or approved therapeutics are available for COVID-19. Therefore, there is much more to learn about the transmissibility, severity, and other features associated with COVID-19, a global effort and investigations are underway to contain its spread.
Clinical trial of Remdesivir in China
Remdesivir is the first experimental medication to treat 2019-novel coronavirus (COVID-19) infection, which is developed by Gilead Sciences, a US-based bio pharmaceutical company. The alternative names of the Remdesivir include Captisol-enabled Remdesivir; Captisol®-enabled GS 5734; GS-5734.
Although, Remdesivir is not yet licensed or approved anywhere globally. However, Remdesivir showed promising preclinical results in vitro and in vivo activity in animal models against the viral pathogens SARS and MERS...
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