Antiviral drug gets regulatory approval

Glenmark Pharmaceuticals on Thursday announced that it received approval from India’s drug regulator, the drugs controller general of India (DCGI), to manufacture and market the oral antiviral drug Favipiravir to treat mild to moderate Covid-19 cases in India. The drug will be marketed under the brand name ‘FabiFlu’.

The drug is known to inhibit virus replication and in April, the company was the first to receive approval from the regulator to conduct clinical trials in the country.

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

Favipiravir, sold under the brand name Avigan in Japan, is used to treat influenza in that country. What Glenmark is producing is a generic version of Avigan, the company had said in an earlier statement.

In the past few months, post the outbreak of Covid-19, multiple clinical trials have been initiated on Covid-19 patients in China, Japan and in the US.

“Having internally developed the Active Pharmaceutical Ingredient (API), and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients,” the company had said.

The treatment duration is a maximum of 14 days.

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