Glenmark Pharmaceuticals today said its generic version of anti-flu drug favipiravir showed promise in a late-stage study of 150 patients with mild to moderate coronavirus infection. About 70% of patients being treated by FabiFlu. generic version of favipiravir, achieved “clinical cure” by the fourth day of the study, compared with about 45% seen in the group treated with standard supportive care, the company said in a statement.
Phase 3 trial demonstrated statistically significant faster time to clinical improvement with Favipiravir treatment in mild to moderate COVID 19 patients, Glenmark said.
Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care.
Favipiravir is a broad spectrum oral antiviral drug that selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2, and is being studied in multiple ongoing international clinical trials.
“The results of the Indian Favipiravir study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed. I have had a chance to independently view the initial results and they are encouraging: Patients randomised to Favipiravir seemed to have faster clinical cure, and more importantly, faster viral clearance than those randomized to the routine care group. I eagerly await the final analysis and results from other ongoing studies from across the globe. Till then, I feel we have enough evidence to consider using Favipiravir in symptomatic COVID-19 patients who have mild to moderate infection,” said Dr Zarir Udwadia, one of the Principal Investigators of this study.
On June 20, Glenmark said that it 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. The manufacturing and marketing approval was granted as part of an accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.