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ニュース

Gilead's Veklury has been approved:Veklury is the First Approved Treatment Option for COVID-19 in the European Union

2020-07-05


Gilead's Veklury has been approved:Veklury is the First Approved Treatment Option for COVID-19 in the European Union

At present,The COVID-19 epidemic continues to spread rapidly around the world. As of 01am, July 04, 2020, there have been more than 11.05 million confirmed cases and more than 525,000 deaths in global.


Remdesivir, an antiviral drug from Gilead Sciences, is a highly anticipated potential drug for COVID-19. In early May, the drug was granted emergency Use Authorization (EUA) by the US FDA for the treatment of hospitalized patients with severe COVID-19. Also in early May, Ridesivir (trade name: Veklury) received the world's first regulatory approval in Japan.


In recent days, There has also been good news on the eu regulatory. The European Commission (EC) has granted Veklury a conditional marketing license to treat novel Coronavirus (SARS-COV-2) infection that causes CoVID-19 (CoVID-19).


Veklury (remdesivir) is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes COVID-19. In recognition of the current public health emergency and based on available clinical data, remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, India, Singapore, the United Arab Emirates and the European Union. Outside of these regions, remdesivir is an investigational, unapproved drug.