NEW DELHI: India’s drug regulator has approved an oral antiviral- favipiravir- for restricted emergency use for COVID-19 patient in India on Friday as the evidence has emerged that it prevents mild and moderate disease from progressing further and reduces viral load within 4-5 days.
Favipiravir manufactured by Glenmark in India is a generic version of the Japanese flu drug Avigan by Fujifilm Toyama Chemical, a subsidiary of Fujifilm Corporation.
The Drug Controller General of India has approved phase 3 trials of the drug in the country after trials in 10 hospitals with 150 patients showed that a short course of this oral antiviral appears to prevent mild and moderate from progressing to severe and cuts viral load within four to five days.
Sources said that in March, Glenmark decided to take a gamble -- on the basis of observations on Covid-19 research in China and Japan -- and decided to start making a generic version of favipiravir after which it conducted clinical trials in 10 hospitals in May and June.
A statement by the company on Friday said: "Glenmark has successfully developed the API and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule, if commercialized, will be marketed under the brand name FabiFlu in India."
Monika Tandon, vice president and head, clinical development of the pharma company said: "Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus."
She added, "The data we get from these trials will point us in a clearer direction with regard to Covid-19 treatment and management."