Glenmark Pharmaceuticals has initiated phase three of clinical trials in India on antiviral tablet Favipiravir, becoming the first company in the country to do so.
It had obtained approval from the Drug Controller General of India (DCGI) in late April. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co Ltd in Japan, a subsidiary of Fujifilm Corporation.
“Clinical trials have commenced and over 10 leading government and private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July or August,” it said in a statement.
Glenmark has successfully developed the active pharma ingredient (API) and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.
The molecule if commercialised will be marketed under the brand name FabiFlu in India.
“Several health and medical experts both in and outside of Glenmark are eager to see the effect that Favipiravir has on Covid-19 cases,” said Monika Tandon, Vice President and Head of Clinical Development, Global Specialty/Branded Portfolio at Glenmark Pharmaceuticals.
“We believe the study results will be significant as there is currently no effective treatment for the virus. The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” she said.
Sujesh Vasudevan, President for India Formulations, Middle East and Africa at Glenmark Pharmaceuticals, said, “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 the accessibility of the product across the country if the clinical trials are successful”.
Glenmark was the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients in India. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 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.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, speciality and OTC business with operations in over 50 countries. Its key therapy focus areas globally are respiratory, dermatology and oncology.