Indian regulators give Glenmark approval to manufacture, sell favipiravir for ‘restricted emergency use’ in treating COVID-19 patients
Glenmark Pharmaceuticals Ltd has received Indian regulatory approval to make and sell oral antiviral drug favipiravir for treating mild-to-moderate COVID-19 infections in the country
Bengaluru: Glenmark Pharmaceuticals Ltd has received Indian regulatory approval to make and sell oral antiviral drug favipiravir for treating mild-to-moderate COVID-19 infections in the country, it said on Friday.
The Mumbai-based company said the approval was part of India’s accelerated approval process and the drug was meant for “restricted emergency use,” meaning patients must sign their consent before being treated by the drug.
Favipiravir is also undergoing trials in other countries to test its efficacy as a COVID-19 treatment.
Japan’s Fujifilm Holdings Corp, which makes favipiravir under the brand name Avigan, said last week its research on the drug as a potential COVID-19 treatment may drag on until July.
Drugmakers across the world have been rushing to develop a treatment or vaccine for the novel coronavirus, which has infected 8.5 million people globally, killing more than 453,000, according to a Reuters tally.
India, the fourth-worst hit country, reported a record daily jump in the number of coronavirus cases on Friday, and the death toll reached 12,573.
The approval for favipiravir in India, which Glenmark plans to sell as "FabiFlu", was granted based on "evaluation of data," the company said in a brief statement to stock exchanges.
The company plans to provide more details in a press briefing on Saturday, it added.
Glenmark began a late-stage trial of favipiravir on COVID-19 patients last month. It is also separately testing a combination of favipiravir and umifenovir, another anti-viral drug, as a potential COVID-19 treatment.
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