DCGI gives nod to Glenmark for clinical trials of Favipiravir tab

Drug Controller General of India (DCGI) granted nod to Glenmark Pharmaceuticals to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients. The company has become the first in India to receive approval.

The Glenmark company have filed the product for clinical trials with the DCGI and has received green signal for conducting the trial on mild to moderate patients.Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections, the company added.

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, according to company. Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation, it further added.

Glenmark Pharmaceuticals Executive Vice President – Global R&D – Sushrut Kulkarni said, “the company is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients. If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients.”

Multiple clinical trials have been initiated on such patients in China, Japan and in the US related to pandemic Covid-19.


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