Glenmark becomes 1st Indian firm to get nod for clinical trials of COVID-19 drug

Glenmark becomes 1st Indian firm to get nod for clinical trials of COVID-19 drug

Mumbai-based Glenmark Pharmaceuticals announced on Thursday that it would begin clinical trials of favipiravir, an anti-viral drug that is considered a potential treatment for coronavirus. This makes Glenmark the first pharma company in India to get approval from the Drug Controller General of India to conduct clinical trials for a potential treatment of coronavirus.

Reuters reported that a “Chinese official told reporters last month that an active ingredient of the drug had been effective, with no obvious side effects, in helping coronavirus patients recover.”

Favipiravir was approved for use as an anti-flu drug in India in 2014. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical, a subsidiary of Japan’s Fujifilm Corporation.

“After having successfully developed the API (active pharmaceutical ingredient) and the formulations … Glenmark is all geared to immediately begin clinical trials on favipiravir on COVID-19 patients in India,” Sushrut Kulkarni, executive vice-president for global R&D, Glenmark Pharmaceuticals, said in a statement.

The company statement noted, “Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently 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”.

The statement adds, “As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomisation.

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