Glenmark gets DCGI nod for favipiravir use in Covid-19

Our Bureau New Delhi | Updated on June 19, 2020 Published on June 19, 2020

Glenmark Pharmaceuticals on Friday received manufacturing and marketing approval for restricted emergency use of oral antiviral drug favipiravir in the treatment of Covid-19 in India.

The approval has been assigned for the treatment of mild to moderate Covid-19 infections by the Drug Controller General of India (DCGI).

“This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of an 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,” Glenmark said in a statement to the exchanges.

Glenmark is the first among its domestic pharma peers to receive DCGI approval for the use of favipiravir in Covid treatment. Originally used in Japan to treat new influenza-like illnesses, the drug is being manufactured by many pharma companies including Strides, Brinton, Last Supergenerics and Glenmark. They have been exporting the drug to countries including Spain, Portugal, Jordan and Turkey, where it is being investigated as a Covid-19 treatment.

Data from Glenmark’s phase three trials evaluating the drug for Covid-19 in an Indian setting is still pending — it is expected by July or August. Glenmark’s brand version of favipiravir is known as ‘FabiFlu’.

Published on June 19, 2020
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