DCGI gives green signal to Glenmark in launching COVID-19 drug 'Favipiravir'

New Delhi, June 20: The Drug Controller General of India (DCGI) nodded assertively for Glenmark Pharmaceuticals Ltd to make and sell oral antiviral drug 'Favipiravir' for treating mild-to-moderate COVID-19 infections in the country. Glenmark Pharmaceuticals Ltd is going to launch it under the brand name FabiFlu.

 

 

Considering the emergency and unmet medical need for COVID-19, the Drug Controller General of India (DCGI) under the fast-tracked approval process granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir (200 mg) tablet. Favipiravir is also undergoing trials in other countries to test its efficacy as a COVID-19 treatment.

 

"This approval comes at a time when cases in India are spiraling like never before, putting tremendous pressure on our healthcare system," Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said."The company hopes that the availability of an effective treatment such as FabiFlu will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option," he added.

 

According to the company, it's the first pharmaceutical firm in India to receive the approval for conducting phase three clinical trials on mild to moderate COVID-19 patients. The Mumbai-based company said the approval was part of India`s accelerated approval process and the drug was meant for "restricted emergency use," meaning patients must sign their consent before being treated by the drug.

 

Japan's Fujifilm Holdings Corp, which makes favipiravir under the brand name Avigan, said last week its research on the drug as a potential COVID-19 treatment may drag on until July. Glenmark began a late-stage trial of favipiravir on COVID-19 patients last month. It is also separately testing a combination of favipiravir and umifenovir, another anti-viral drug, as a potential COVID-19 treatment.

 

Favipiravir was approved in Japan in 2014 for the treatment of novel or re-emerging influenza virus infections. It selectively inhibits RNA polymerase, which is necessary for viral replication. The company said Favipiravir has shown clinical improvement of up to 88 percent in mild to moderate COVID-19 cases.