The drug regulator has approved Favipiravir for the treatment of mild to moderate Covid-19 patients in India.
In a filing with the exchanges on Friday, Glenmark Pharmaceuticals said that it has just received the manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug Favipiravir (FabiFlu) for the treatment of mild to moderate Covid-19 patients in the country.
This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical needs of the Covid-19 outbreak, Glenmark said.
“It is for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation,” the company said.
Glenmark was the first pharmaceutical company in India to be given approval by the drug regulator to conduct Phase 3 clinical trial of Favipiravir antiviral tablets for Covid-19 patients. Patients from over 10 leading government and private hospitals were enrolled for the study.
Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.
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 commercialised will be marketed under the brand name FabiFlu in India.