Glenmark Pharmaceuticals Ltd has received approval from Drug Controller General of India (DCGI) to make and sell oral antiviral drug Favipiravir for the treatment of mild to moderate COVID-19 infections in the country, it said on Friday.
The approval of the Favipiravir 200 mg (FabiFlu) tablet was granted on the recommendation of the Special Subject Expert Committee (SEC) on Covid-19.
The Mumbai-based company said the approval was part of India ‘s accelerated approval process and the medication was intended for “restricted emergency use,” meaning that the patient would have to give informed consent before treatment is initiated.
FabiFlu is expected to be priced at around Rs 100 per tablet, with an average treatment cost of around Rs 3000 per patient, depending on the viral load.
This is the second medication that has recently been approved for emergency use following the approval by the US-based Gilead Sciences of injectable remdesivir in India for serious Covid-19 infections.
Last month, Glenmark began a late-stage trial of favipiravir in COVID-19 patients. A combination of favipiravir and umifenovir, another anti-viral drug, as a potential treatment with COVID-19, is also tested separately.
Antiviral drug Favipiravir has shown promising global results in Japan, China and Italy and is confirmed to have been commercialized in the UAE and Bangladesh. The drug Favipiravir has recently been approved for Covid-19 therapy in Russia.
Japan’s Fujifilm Holdings Corp, which manufactures favipiravir under the brand name Avigan, which has been approved for the treatment of influenza in Japan since 2014, and other viral strains that do not respond to other therapies. The medication that was originally used to treat Ebola became an off-patent last year, which means that generic copies can be introduced anywhere in the world.