Pharmaceutical giant Glenmark on Wednesday said its Phase-3 clinical trials of antiviral drug Favipiravir showed improvement in mild and moderate novel coronavirus patients.
In a statement on Wednesday, 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 29% faster that those receiving standard supportive care.
“Results from the Phase-3 trials showed improvements for the primary efficacy endpoint with 28.6 per cent faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment arm compared to those in the control arm,” Glenmark statement read.
The trials were conducted on 150 mild to moderate patients.
“Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets for up to maximum of 14 days, along with standard supportive care. Randomisation was stratified based on disease severity into mild (90 patients) and moderate (60 patients),” the statement read.
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. Adverse 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 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.
Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It was granted approval in Russia for treatment of Covid-19 in May 2020 and is being prescribed to patients in many countries across the globe under compassionate use for the treatment of Covid-19 infection.
It also is being tested in close to 20 clinical trials across 3,000+ Covid-19 patients globally, including ongoing clinical trials in the US, Canada, Japan and Italy.
