BackGlenmark starts clinical trial of potential covid-19 drug favipiravir in India
Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the studyAbout 150 patients with mild to moderate covid-19 will be enrolled in 10 hospitals for the randomized, open-label study
PremiumNEW DELHI: Glenmark Pharmaceuticals Ltd has initiated phase 3 clinical trials in India on the use of generic antiviral drug favipiravir for treatment of mild to moderate covid-19, a study which the Mumbai-based drug-maker expects to complete by August.
Drug Controller General of India V.G. Somani had in late April approved Glenmark’s plan to conduct phase 3 trials on the use of the drug. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study, the company said in an exchange filing.
Favipiravir is a generic version of Avigan of Japan’s Fujifilm Toyama Chemical Co Ltd, a subsidiary of Fujifilm Corporation.
About 150 patients with mild to moderate covid-19 will be enrolled in 10 hospitals for the randomized, open-label study.
“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," Sujesh Vasudevan, Glenmark’s president for formulations business in India, Middle East and Africa, was quoted as saying in the filing.
So far, nine sites for the study have been selected, with six hospitals in Maharashtra, two in Gujarat and the All India Institute of Medical Sciences in Chhattisgarh, as per the government’s clinical trial registry.
As per the registry, patients with severe covid-19, like those requiring ventilator support, will not be included in the trials.
Favirpiravir has shown some early promise in treating mild to moderate covid-19, and trials of the broad spectrum antiviral drug are happening in various countries like Japan and the US.
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