Corona Virus vaccine: Favipiravir shows positive results in Phase-3 clinical trails

New Delhi: Pharmaceutical giant Glenmark said its Phase-3 clinical trials of antiviral drug Favipiravir showed improvement in mild and moderate Coronavirus patients.

In a statement released, Glemnmark said Covid-19 patients administered with Favipiravir reported faster clinical cure and viral clearance as compared to those with routine care. Data showed that patients receiving FabiFlu shook off the virus about 28% faster than those receiving standard supportive care.

The trials were conducted on 150 mild to moderate patients.

According to the statement, "Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets for up to a maximum of 14 days, along with standard supportive care. Randomisation was stratified based on disease severity into mild (90 patients) and moderate (60 patients)." Glenmark added that Favipiravir was well-tolerated with no serious adverse events (SAEs) or deaths.

"One SAE occurred in the control arm and resulted in death due to worsening clinical disease and acute respiratory distress syndrome (ARDS) attributed to Covid-19 infection. Unfavourable events were reported in 26 patients in the Favipiravir treatment arm (35.6 per cent) as compared to six patients in the control arm (8 per cent). However, most adverse events were mild to moderate and none led to drug discontinuation or dosing adjustments," the statement added.

Dr Zarir Udwadia, one of the principal investigators of this study, said the initial results are encouraging. "Patients randomised to Favipiravir seemed to have the faster clinical cure, and more importantly, faster viral clearance than those randomised to the routine care group."

On June 20, Glenmark had received manufacturing and marketing approval from India's drug regulator for FabiFlu -- making it the first oral approved medication in India for the treatment of mild to moderate Covid-19.