Glenmark Prescribed pills has initiated Segment-3 clinical trials in India on antiviral tablet Favipiravir, for which it obtained approval from India’s drug regulator DCGI in leisurely April, the company has said in an announcement.
Glenmark is the first company in India to provoke Segment-3 clinical trials on Favipiravir for COVID-19 patients in India, it said.
Favipiravir is a generic model of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.
Clinical trials admire commenced and over 10 leading authorities & private hospitals in India are being enrolled for the watch.
Glenmark estimates that the watch would complete by July/August 2020. It has developed the API and the formulations for the product thru its in-apartment R&D team.
Favipiravir has demonstrated exercise in opposition to influenza viruses and has been well-liked in Japan for the medication of novel influenza virus infections.
The molecule, if commercialised, will be marketed under the emblem title ‘FabiFlu’ in India.
Monika Tandon, vice-president & head, clinical trend, global distinctiveness/branded portfolio, Glenmark Prescribed pills Ltd., said, “Several health and scientific examiners, each and each in and outside of Glenmark are desirous to see the attain that Favipiravir has on COVID-19 cases.”
“We imagine the watch outcomes will be principal as there might be currently no efficient medication for the virus,” she added.
“The files we rep from these trials will level us in a clearer route with regard to COVID-19 medication and management,” Ms. Tandon said.
Sujesh Vasudevan, president, India Formulations, Center East and Africa, Glenmark Prescribed pills Ltd. said “Our effort is to delivery a medication for COVID-19 patients as soon as doable and management the spread of the pandemic.”
“We are able to operate all it takes to form obvious accessibility of the product across the country if the clinical trials are a hit,” he said.
As per the well-liked clinical trial protocol, 150 matters with gentle to practical COVID-19 will be randomised in the watch in a 1:1 ratio to Favipiravir with celebrated supportive care or standalone celebrated supportive care.
Remedy length is a maximum of 14 days and the entire watch length will be a maximum of 28 days from randomisation.