Glenmark Pharmaceuticals has initiated Phase-3 clinical trials in India on antiviral tablet Favipiravir, for which it received approval from India’s drug regulator DCGI in late April, the company has said in a statement.
Glenmark is the first company in India to initiate Phase-3 clinical trials on Favipiravir for COVID-19 patients in India, it said.
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Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.
Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study.
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Glenmark estimates that the study would complete by July/August 2020. It has developed the API and the formulations for the product through its in-house R&D team.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.
The molecule, if commercialised, will be marketed under the brand name ‘FabiFlu’ in India.
Monika Tandon, vice-president & 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,” she added.
“The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” Ms. Tandon said.
Sujesh Vasudevan, president, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd. said “Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic.”
“We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful,” he said.
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.
