New Delhi: Glenmark Pharmaceuticals said Wedensday that the Phase 3 clinical trial of antiviral drug Favipiravir is giving hope. Glenmark Pharmaceuticals said Favipiravir is helping mild to moderate COVID-19 patients get clinical improvement in ‘significantly faster time’.
Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 per cent 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.
The results also demonstrated 40 per cent faster achievement of ‘clinical cure’ defined as the physician’s assessment of normalisation of clinical signs – temperature, oxygen saturation, respiratory rate and cough, the statement added.
“It should be stated that 69.8 per cent 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 per cent 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 five days versus two days in the control arm, the company added.
‘Favipiravir’ was well tolerated with no serious adverse events or deaths. 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.
“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 company had announced June 20 the receiving, manufacturing and marketing approval from India’s drug regulator for Favipiravir for the treatment of mild to moderate COVID-19. The company sells the drug under the brand name ‘FabiFlu’ at a price of Rs 75 per tablet.
Shares of Glenmark Pharmaceuticals settled at Rs 413.70 per scrip on BSE, down 0.13 per cent from its previous close.
PTI