Glenmark Pharmaceuticals said on Thursday it has received approval from the Drug Controller General of India (DCGI) to conduct clinical trials on Favipiravir anti-viral tablets on COVID-19 patients.
The product is a generic version of Avigan of Fujifilm Toyama Chemical Co Ltd in Japan, a subsidiary of Fujifilm Corporation.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Multiple clinical trials have been initiated on COVID-19 patients in China, Japan and the United States.
"Having internally developed the active pharma ingredient (API) and 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 on date, Glenmark is the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients in India.
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.
"After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India," said Sushrut Kulkarni, Executive Vice President for Glenmark's global research and development division.
"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," Kulkarni added.
Glenmark is a global research-led pharmaceutical company with presence across generics, speciality and OTC business with operations in over 50 countries. Its key therapy focus areas globally are respiratory, dermatology and oncology.
( With inputs from ANI )