Glenmark’s Favipiravir Drug Shows Positive Results in Phase 3

On Thursday Pharmaceutical Giant Glenmark, announced positive results for a phase 3 trial at seven clinical sites, which recorded faster clinical and viral clearance for COVID-19 (mild to moderate) patients receiving Favipiravir in India.

The company stated that patients treated with Favipiravir have shown faster clinical cures and faster viral clearance as compared to the patients in a standard care team.

“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 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,” stated the company statement.

The treatment arm (3 days) for Favipiravir shown 40% faster improvement of physical signs like temperature, oxygen saturation, respiratory rate and cough as compared to the control arm (five days).

By Day 4, roughly 69.8% of patients in the treatment arm Favipiravir obtained the clinical cure, a statistically significant improvement compared with 44.9% in the control arm.

A randomized open-label multicenter study for mild- to moderate-patients was done with 150 patients, randomized within a 48-hr RT-PCR positive testing window of COVID-19, for evaluating the efficiency and safety of a Favipiravir treatment arm versus standard supportive alone (control arm).

Favipiravir tablets were provided to patients on day 1, 3600 mg, followed by 800 mg twice daily for up to 14 days and normal supporting treatment were given. The randomization was stratified to mild (90 patients) and moderate (60 patients) on the basis of disease severity.