COVID-19 cure Remdesivir gets approved in Japan

  • Gilead Sciences, Inc. announced that Veklury (remdesivir) has been granted a regulatory approval
  • This is eyed to finally end SARS-CoV-2 infection in the country and possibly around the world
  • However, Gilead made it clear that remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy

As reported in the website of Pharmaceutical Technology, it was on the 16th of January 2020 when the first case of corona virus in Japan was reported. It also said that it is the second country to report a confirmed case of the virus outside China.

COVID-19 pandemic has been threatening countries around the globe during the past months and people are still trying to find the cure to finally end the scare. Antibodies from blood plasma and avigan are just some of the remedies they tried to hopefully stop the virus from claiming lives.

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On May 07, 2020, Gilead Sciences, Inc. announced that Veklury (remdesivir) has been granted a regulatory approval by the Japanese Ministry of Health, Labour and Welfare (MHLW). This is eyed to finally end SARS-CoV-2 infection in the country and possibly around the world.

Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences stated that the Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan which is a reflection of the exceptional circumstances of this pandemic.

The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic’

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He also thanked Japanese MHLW for their leadership and collaboration, as they work together to respond to this public health emergency.

We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.’

Gilead said that due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of COVID-19. It also added that in the United States, it is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established.  It was also clarified that the distribution of remdesivir in the United States has been authorized only for the treatment of hospitalized patients with severe COVID-19.

Image via Freepik

However, Gilead made it clear that remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy while they continue to work with global regulatory authorities to ensure appropriate access to remdesivir.