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Strides Pharma Science has obtained approval from the Drug Controller General of India (DCGI) to conduct trials of antiviral drug Favipiravir as a potential Covid-19 treatment in the country.
The approval is for a bio-equivalence study, which is expected to launch soon.
Favipiravir is a generic version of Avigan, which was initially developed in Japan by Fujifilm to treat influenza. The drug is being currently studied in multiple trials for the treatment of patients infected with Covid-19.
Strides Pharma has been manufacturing and exporting the drug to Gulf countries to treat patients under a programme for Covid-19.
The company is producing Favipiravir at its facility in Bengaluru, which can manufacture up to six billion units of solid orals per year, according to Business Standard news agency.
Strides is the second Indian company to receive regulatory approval for studying Favipiravir in Covid-19 trials, following Glenmark Pharmaceuticals, which commenced Phase III trials earlier this month.
Glenmark developed the drug’s API and formulations internally. If commercialised in India, the medicine will be available under the brand name ‘FabiFlu’.
According to the approved study protocol, Glenmark’s 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.
Furthermore, Russian scientists reported positive data for the drug in a multi-centre trial involving Covid-19 patients. ChemRar Group and The Russian Direct Investment Fund (RDIF) reported that 60% of 40 patients treated with the drug tested negative for coronavirus following five days of therapy.
The findings are said to be consistent with results from studies performed in China, which also showed a decrease in the disease duration from 11 days to four-five days.