Japan to approve remdesivir for coronavirus patients in May

KYODO NEWS

Prime Minister Shinzo Abe said Monday that Japan will soon approve the anti-viral drug remdesivir for the treatment of coronavirus patients, in what will be the country's first such decision amid the pandemic.

A government official said separately that the drug will be approved as early as next month to treat patients with COVID-19, the respiratory illness caused by the novel coronavirus, as moves to develop therapeutic drugs and vaccines have been accelerating around the globe.

(Supplied file photo shows anti-viral drug Remdesivir)

"The pharmaceutical approval (of remdesivir) will be possible shortly," Abe told a parliamentary session.

Remdesivir has been developed by U.S. biopharmaceutical company Gilead Sciences Inc. as a possible treatment for Ebola.

A clinical test conducted by an international team on patients with severe COVID-19 symptoms will conclude this month.

The New England Journal of Medicine recently published a study showing the drug's effectiveness in nearly 70 percent of 53 coronavirus patients with severe symptoms, while it caused serious side-effects, such as deterioration of kidney function, in a quarter of them.

A spokesperson of the Japan unit of Gilead Sciences said, "We are currently conducting clinical tests and are focused on confirming the drug's efficacy and safety."

Once an application by Gilead Sciences is made, the Japanese government is set to fast-track its approval. This streamlining of the process -- which involves postponing reports on domestic clinical tests to a later date -- is available on condition that the drug has been approved in another country.

In Japan, the anti-influenza drug Avigan is also going through clinical tests on COVID-19 patients, which will last through June. A scientific study in China has shown its efficacy in treating the disease.

The Japanese government has requested Fujifilm Toyama Chemical Co., a group firm of Fujifilm Holdings Corp., to boost production of Avigan, also known as favipiravir. As it is feared to cause birth defects, it cannot be administered to expecting mothers or those who may become pregnant.

Also Monday, Shionogi & Co. said it will develop a vaccine for the novel coronavirus, aiming to start clinical trials this year.

The Japanese company has decided to develop a recombinant protein vaccine for the virus that causes COVID-19 through its subsidiary UMN Pharma Inc., while also seeking to discover therapeutic drugs for the disease. Shionogi said it is looking to offer the vaccine for 10 million people.

The company is coordinating its plans with relevant parties including the Ministry of Health, Labor and Welfare.

 

 


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