Glenmark Pharma gets DCGI nod for clinical trials of Favipiravir tablets on COVID-19 patients

By Sumit Blogs -

glenmark-pharma-gets-dcgi-nod-for-clinical-trials-of-favipiravir-tablets-on-covid-19-patients

By Economic Times – Glenmark Pharma gets DCGI nod for clinical trials of Favipiravir tablets on COVID-19 patients The drug sold under brand name Avigan by Fujifilm Toyama Chemical has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.Last Updated: Apr 30, 2020, 12.29 PM ISTAFPGlenmark Pharmaceuticals on Thursday said that it has received the Indian drug controller’s approval to conduct clinical trial on Favipiravir , the anntiviral drug that is being used in the treatment of Covid-19 in few countries. The drug sold under brand name Avigan by Fujifilm Toyama Chemical has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.

Fujifilm too has started phase 3 trial on this drug and also increased its production. Glenmark’s announcement comes at a time when another Indian company, Strides Pharma said that it has already started shipping the drug to countries in the gulf region.

“Having internally developed the API and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients”, the company said in a statement. Adding that it is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India.

As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 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 maximum for 28 days from randomization.

“Glenmark is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients.” said Sushrut Kulkarni, Executive Vice President – Global R&D, Glenmark Pharmaceuticals Limited.
Also ReadStrides Pharma awaiting govt nod for Favipiravir, says CEO R AnanthanarayananStrides Pharma develops Favipiravir antiviral tablets; drug shows positive outcome in COVID-19 treatmentCommenting feature is disabled in your country/region.Copyright © 2020 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service

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