Glenmark’s favipiravir hastens recovery among mild to moderate coronavirus disease (Covid-19) cases, the pharma major said as it announced results of its phase III clinical trials on Wednesday.
“Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6% 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…,” the company said in a statement.
“…40% faster achievement of clinical cure defined as the physician’s assessment of normalization of clinical signs – temperature, oxygen saturation, respiratory rate and cough with a statistically significant reduction in median time to clinical cure in the Favipiravir treatment arm (3 days)…, compared to the control arm (5 days)….”, the statement said. Favipiravir is a broad-spectrum oral antiviral drug that inhibits the Sars-Cov-2 virus, which causes Covid-19, from replicating.
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The India trials were conducted on 150 patients across seven clinical sites in India. The open-label randomized, multicenter clinical trial, evaluated the efficacy and safety of favipiravir plus standard supportive care (favipiravir treatment arm), versus standard supportive care alone (control arm), in mild to moderate cases.
“We are encouraged with the results and these indicate that early treatment with favipiravir may improve clinical outcomes for mild to moderate patients and could prevent patients from progressing to acute respiratory distress syndrome and mortality,” said Monika Tandon, vice president, and head, clinical development, Glenmark.
One of the principal investigators of the study, Dr Zarir Udwadia, said, “…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 faster viral clearance than those randomized to the routine care group…”