Glenmark Prescribed drugs has initiated Section-Three scientific trials in India on antiviral pill Favipiravir, for which it acquired approval from India’s drug regulator DCGI in late April, the corporate has mentioned in a press release.
Glenmark is the primary firm in India to provoke Section-Three scientific trials on Favipiravir for COVID-19 sufferers in India, it mentioned.
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Favipiravir is a generic model of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Company.
Medical trials have commenced and over 10 main authorities & personal hospitals in India are being enrolled for the research.
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Glenmark estimates that the research would full by July/August 2020. It has developed the API and the formulations for the product by way of its in-house R&D group.
Favipiravir has demonstrated exercise in opposition to influenza viruses and has been permitted in Japan for the therapy of novel influenza virus infections.
The molecule, if commercialised, shall be marketed beneath the model title ‘FabiFlu’ in India.
Monika Tandon, vice-president & head, scientific improvement, international specialty/branded portfolio, Glenmark Prescribed drugs Ltd., mentioned, “A number of well being and medical consultants, each in and outdoors of Glenmark are wanting to see the impact that Favipiravir has on COVID-19 circumstances.”
“We consider the research outcomes shall be important as there may be at the moment no efficient therapy for the virus,” she added.
“The information we get from these trials will level us in a clearer route with regard to COVID-19 therapy and administration,” Ms. Tandon mentioned.
Sujesh Vasudevan, president, India Formulations, Center East and Africa, Glenmark Prescribed drugs Ltd. mentioned “Our effort is to launch a therapy for COVID-19 sufferers as quickly as potential and management the unfold of the pandemic.”
“We’ll do all it takes to make sure accessibility of the product throughout the nation if the scientific trials are profitable,” he mentioned.
As per the permitted scientific trial protocol, 150 topics with delicate to average COVID-19 shall be randomised within the research in a 1:1 ratio to Favipiravir with normal supportive care or standalone normal supportive care.
Therapy length is a most of 14 days and the whole research length shall be a most of 28 days from randomisation.