Glenmark gets DGCI nod for clinical trial

NEWDELHI:Glenmark Pharmaceuticals on Thursday announced that it has received approval from India’s drug regulator, the drugs controller general of India (DCGI), to conduct clinical trials on antiviral drug Favipiravir against Covid-19.

Favipiravir, sold under the brand name Avigan of Fujifilm Toyama Chemical Co. Ltd, Japan, a subsidiary of Fujifilm Corporation, is an antiviral medication used to treat influenza in Japan.

What Glenmark is producing is a generic version of Avigan, said the company in a statement.

The DCGI approved to conduct trials on Favipiravir antiviral tablets on Covid-19 patients, making Glenmark the first pharmaceutical firm in India to be given an approval to start the trial.

Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.

In the past few months, 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 said in a statement.

As per the protocol, 150 subjects with mild to moderate Covid-19 will be randomized in the study in a 1:1 ratio to Favipiravir, with standard supportive care or standalone standard supportive care. The treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization.