NE HEALTH BUREAU
NEW DELHI, JULY 22
Glenmark Pharmaceuticals Ltd, a global research-led pharmaceutical company, on Wednesday said Phase 3 clinical trial of antiviral drug Favipiravir in mild to moderate COVID-19 patients demonstrated significantly faster time to clinical improvement.
Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 percent faster viral clearance in the overall population in the Favipiravir plus standard supportive care compared to those in the standard supportive care alone (control arm), Glenmark said in a statement.
Dr. Zarir Udwadia, one of the Principal Investigators of this study, commented: “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 a 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.”
“We are encouraged with the top-line results and these indicate that early treatment with Favipiravir may improve clinical outcomes for mild to moderate patients and could potentially prevent patients from progressing to ARDS and mortality,” Glenmark Vice President & Head – Clinical Development, Global Specialty/Branded Portfolio Monika Tandon said.
The results also demonstrated a 40 percent faster achievement of ”clinical cure” defined as the physician’s assessment of normalization of clinical signs – temperature, oxygen saturation, respiratory rate, and cough, it added.
“69.8 percent of patients in the Favipiravir plus standard supportive care (Favipiravir treatment arm) achieved clinical cure by Day 4, which was statistically significant compared to 44.9 percent observed in the control arm,” the statement said.
Among patients who clinically deteriorated and required oxygen support, those receiving Favipiravir had a longer median time to first-time use of oxygen of 5 days versus 2 days in the control arm, it added.
Glenmark’s Favipiravir was well tolerated with no serious adverse events or deaths in the Favipiravir treated arm. Adverse events were reported in 26 patients in the Favipiravir treatment arm as compared to six patients in the control arm, it added.
However, most adverse events were mild to moderate, and none led to drug discontinuation or dosing adjustments, the statement said.
