Global pharmaceutical company, Glenmark, has initiated phase three clinical trials in India on Favipiravir. The company had received approval for the trial from India’s drug regulator, DCGI in late April.
With the third trial, Glenmark will be the first company in India to initiate phase three clinical trials on antiviral for COVID-19 patients in India. Over 10 government and private hospitals in India are being enrolled for the trials. The company expects the trial to conclude by July or August 2020.
As per the approved clinical trial protocol, 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 a maximum of 28 days from randomisation.
Dr Monika Tandon, Vice President and Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd, said, “Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus.”
Adding to Tandon, Sujesh Vasudevan, President, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd, said, “We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful.”
Favipiravir is a generic version of Avigann of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Favipiravir has been approved in Japan for the treatment of novel influenza virus infections.