Favipiravir approved for treatment of mild to moderate Covid patients in India

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epa04368952 A Fujifilm Holdings employee displays Avigan tablets, an experimental drug developed and manufactured by Japanese drug maker Toyama Chemical Co., Ltd. ,in Tokyo, Japan, 26 August 2014. The generic name of the Avigan drug is Favipiravir. Japanese Chief Cabinet Secretary Yoshihide Suga said on 25 August 2014 during a regular news conference that Japan was ready to provide an experimental drug developed by Japan's drug manufacturer Toyama Chemical Co., Ltd., subsidiaries under Fujifilm Holdings, to fight against the global tide of the deadly Ebola virus, if the World Health Organization (WHO) requests it. The drug, called Avigan, is a tablet-format anti-influenza drug developed by Toyama Chemical Co Ltd. It was approved in March by the Health Ministry. Avigan inhibits the replication of the virus genetic material inside infected cells, which prevents propagation. This is a new mechanism, compared with previous antiviral drugs that just tackle propagation, according to the company's website. In early August, the WHO declared the Ebola outbreak an international public health emergency. There is no available cure or vaccine for the deadly virus. The unapproved Ebola drug ZMapp was given to two US aid workers, who are said to have shown strong improvement, and a Spanish missionary priest, who died in Madrid this month. EPA/KIMIMASA MAYAMA
epa04368952 A Fujifilm Holdings employee displays Avigan tablets, an experimental drug developed and manufactured by Japanese drug maker Toyama Chemical Co., Ltd. ,in Tokyo, Japan, 26 August 2014. The generic name of the Avigan drug is Favipiravir. Japanese Chief Cabinet Secretary Yoshihide Suga said on 25 August 2014 during a regular news conference that Japan was ready to provide an experimental drug developed by Japan’s drug manufacturer Toyama Chemical Co., Ltd., subsidiaries under Fujifilm Holdings, to fight against the global tide of the deadly Ebola virus, if the World Health Organization (WHO) requests it. The drug, called Avigan, is a tablet-format anti-influenza drug developed by Toyama Chemical Co Ltd. It was approved in March by the Health Ministry. Avigan inhibits the replication of the virus genetic material inside infected cells, which prevents propagation. This is a new mechanism, compared with previous antiviral drugs that just tackle propagation, according to the company’s website. In early August, the WHO declared the Ebola outbreak an international public health emergency. There is no available cure or vaccine for the deadly virus. The unapproved Ebola drug ZMapp was given to two US aid workers, who are said to have shown strong improvement, and a Spanish missionary priest, who died in Madrid this month. EPA/KIMIMASA MAYAMA

The drug regulator has approved Favipiravir for the treatment of mild to moderate Covid-19 patients in India.

In a filing with the exchanges on Friday, Glenmark Pharmaceuticals said that it has just received the manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug Favipiravir (FabiFlu) for the treatment of mild to moderate Covid-19 patients in the country.

This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical needs of the Covid-19 outbreak, Glenmark said.

“It is for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation,” the company said.

Glenmark was the first pharmaceutical company in India to be given approval by the drug regulator to conduct Phase 3 clinical trial of Favipiravir antiviral tablets for Covid-19 patients. Patients from over 10 leading government and private hospitals were enrolled for the study.

Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.

Glenmark has successfully developed the API and the formulations for the product through its inhouse R&D team.

Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule if commercialised, will be marketed under the brand name FabiFlu in India.

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