Glenmark gets regulatory approval to conduct Clinical Trials on Favipiravir Antiviral tablets for COVID-19 patients in India

Mumbai: Pharma major Glenmark Pharmaceuticals on Thursday said that it has received approval from the Drug Controller General of India (GCGI) to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.
With this, Glenmark has become the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients in the country.
“..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” said Sushrut Kulkarni, Executive Vice President – Global R&D, Glenmark.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. In the last few months, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US.
As per the clinical trial protocol approved by the Indian Drug Regulator, as many as 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. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization.