The Drug Controller General of India (DCGI) has given the nod for clinical trials of Glenmark Pharmaceuticals’ Favipiravir antiviral tablets on COVID-19 patients, the company said on Thursday (30).
Glenmark is the first company in India to receive such an approval from the drug controller, a statement said. It further said that the active pharmaceutical ingredients (API) and the formulations for the tablets were developed internally.
The tablets will be tried 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, Glenmark said.
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, the company said.
Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation, it added.
The pharma company said its product is a generic version of Japan-based Fujifilm Toyama Chemical Co Ltd’s Avigan tablets.
“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 Pharmaceuticals.