Glenmark Initiates Phase 3 Clinical Trials For COVID19 Treatment In India
Glenmark is the first company in India to initiate Phase 3 clinical trials on Antiviral tablet Favipiravir for COVID19 treatment in India. Glenmark Pharma received the approval for conducting this clinical trial from India’s drug regulator DCGI in last week of April 2020.
Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark expects the study completion by July/August 2020.
Favipiravir is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd. based in Japan and a subsidiary of Fujifilm Corporation.
Glenmark has successfully developed the API and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses. It has been approved in Japan for the treatment of novel influenza virus infections. The molecule if commercialized will be marketed under the brand name ‘FabiFlu®’ in India.
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Dr. Monika Tandon, Vice President & Head, Clinical Development, 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 COVID19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus.”
“Our effort is to launch a treatment for COVID19 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”, said Mr. Sujesh Vasudevan, President, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd.
As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID19 will be randomized 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 randomization.
