Glenmark Pharmaceuticals recently announced top-line results from the third phase of the clinical trials of Favipiravir in mild to moderate Covid-19 patients. The trial was conducted across seven clinical sites in 150 patients in India. Favipiravir is a broad spectrum oral antiviral drug. It selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2.
Patients selected through the process of randomisation were stratified based on disease severity into mild (90 patients) and moderate (60 patients). Results from the Phase III trials showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance. Dr. Zarir Udwadia, one of the principal investigators of this study, said, “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.”
Dr. Monika Tandon, Vice President and Head - Clinical Development, Global Specialty/Branded Portfolio, said, “The top-line results 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.”
Anurag Khera, Senior Vice President - Corporate Affairs, Glenmark, in a clarification letter to Dr. VG Somani, Director General of Health Services, Central Drugs Standard Control Organisation, stated that compared to other therapies approved for emergency use in Covid-19 patients, Favipiravir (FabiFlu) is much more economical and an effective treatment option. It is available at a reduced cost of Rs 75/tablet. The company stated that they never claimed the tablet is effective for patients with comorbidities like diabetes and hypertension