From Nov 2011 to July 2013, as many as 74 pharma sector proposals were 
approved by FIPB
From Nov 2011 to July 2013, as many as 74 pharma sector proposals were approved by FIPB

Glenmark Pharmaceuticals on Tuesday said it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients in India.

The Mumbai-based company had received approval from Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients.

Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India, it said in a statement.

Clinical trials have commenced and over ten leading government and private hospitals are being enrolled for the study, it added.

Glenmark estimates study completion by July/August 2020, it said.

As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomised 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 randomisation.

"Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus," Glenmark Pharmaceuticals Vice President & Head Clinical Development, Global Specialty/Branded Portfolio Monika Tandon said.

The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management, she added.

The company said it aims to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic.

Favipiravir, which is a generic version of Japan-based Fujifilm Toyama Chemical's Avigan, has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.

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