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Glenmark Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) to evaluate antivirial drug favipiravir in clinical trials to treat patients with Covid-19.
Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug Avigan, which holds approval in Japan for treating new influenza virus infections.
Glenmark developed the drug’s API and formulations internally. Following the regulatory approval, the new trial will assess the product in Covid-19 patients with mild to moderate infection.
Around 150 patients will be enrolled for the study. Participants will be given favipiravir plus standard supportive care or only standard supportive care.
Treatment duration of the trial is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.
Glenmark Pharmaceuticals Global R&D executive vice-president Sushrut Kulkarni said: “After having successfully developed the API and the formulations through its in-house R&D team, 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. If the clinical trials are successful, favipiravir could become a potential treatment for Covid-19 patients.”
Favipiravir is already in several Covid-19 clinical trials in China, Japan and the US.
Last month, Fujifilm initiated a Phase II study of Avigan (favipiravir) to treat Covid-19 patients in the US. The trial will evaluate the drug’s safety and efficacy as a potential Covid-19 therapy.
The company also commenced a Phase III trial of Avigan for the treatment of Covid-19 patients in Japan.
In addition to treatment studies for Covid-19, Fujifilm is working to boost the production of Avigan to help fight the pandemic.
The drug is produced and distributed upon request by the government of Japan. Avigan was never distributed in the market and is not available at hospitals and pharmacies in Japan or internationally.