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India-based Glenmark Pharmaceuticals has started Phase III clinical trials of anti-flu drug favipiravir as a potential treatment for patients suffering from Covid-19 in the country.
The company, which is the first in India to conduct Phase III trials of the drug for Covid-19, secured approval from the Drug Controller General of India (DCGI).
Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug Avigan, which showed activity against influenza viruses and holds approval in Japan for treating new influenza virus infections.
Glenmark developed the drug’s API and formulations internally. If commercialised in India, the drug will be available under the brand name ‘FabiFlu’.
Glenmark Pharmaceuticals India Formulations, Middle East and Africa president Sujesh Vasudevan 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 accessibility of the product across the country if the clinical trials are successful.”
According to the approved study protocol, the Phase III trial will enrol 150 patients with mild to moderate Covid-19. More than ten government and private hospitals in India are being recruited for the trial.
Participants will be given favipiravir plus standard supportive care or standard supportive care alone. Treatment duration of the study is a maximum of 14 days and the total duration will be a maximum of 28 days from randomisation.
Glenmark Pharmaceuticals Global Specialty/Branded Portfolio clinical development vice-president and head Dr Monika Tandon said: “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.”
The company expects the study to be completed by July or August this year.