Glenmark Pharmaceuticals (Glenmark), a manufacturer of generic formulation products and API, announced that it has conducted Phase 3 clinical study on oral antiviral Favipiravir (FabiFlu) drug.

The oral antiviral medication Favipiravir, that prevents the replication phase of the virus life-cycle, leads to significant improvement in clinical cure in patients with mild to moderate COVID-19. These findings were observed in a randomized, controlled Phase 3 clinical study conducted by Glenmark Pharmaceuticals, and the results are now published online in The International Journal of Infectious Diseases (IJID).

The Phase 3 study with antiviral drug Favipiravir, brand name FabiFlu, was conducted in 150 patients as part of a randomised, open label, multicenter, Phase 3 study. Favipiravir was found to provide multiple treatment benefits, demonstrated by faster time to clinical cure, and significantly delayed the need for supportive oxygen therapy. Additionally, patients of confirmed COVID-19 with moderate symptoms were discharged from hospital earlier than those patients that did not receive Favipiravir, with the median time to clinical cure reduced by 2.5 days compared with the control group.

Favipiravir is an antiviral medication that works by inhibiting a viral enzyme called RdRP (RNA dependent RNA polymerase), thereby halting the virus's replication cycle. This helps control the multiplication of the virus and prevents its spread in the patient.

Zarir F. Udwadia. MD, FRCP, FCCP, Breach Candy Hospital, Mumbai commented "Every claim for the efficacy of a new drug in COVID-19 must be backed by evidence from a clinical trial. Glenmark has done just that with Favipiravir. Their well-designed trial in 150 patients showed Favipiravir resulted in a significantly improved time to clinical cure and rapid viral clearance. Based on this I would consider the use of this anti-viral drug in symptomatic patients with mild to moderate COVID-19. I eagerly await the results of similar trials presently being conducted in Boston and at Stanford."

Robert Crockart, Chief Commercial Officer Glenmark Pharmaceuticals said, "From the first reported case of COVID-19, our every effort was to bring a viable, safe and effective treatment option to patients in a timely manner. It is encouraging to see our trial results now published in a reputed global medical journal, which we hope will support other countries in their fight against this disease."

"The study, which was undertaken by Glenmark Pharmaceuticals, at a time when the number of cases for infections were dramatically increasing around the globe, demonstrates Glenmark's commitment to ensuring all patients have access to affordable medication, to make a positive impact on their quality of life," said Monika Tandon, Vice President & Head - Clinical Development, Global Specialty/Branded Portfolio at Glenmark.

In June 2020, Glenmark received manufacturing and marketing approval from India's drug regulator for Favipiravir (FabiFlu), making it the first oral approved medication in India for the treatment of mild to moderate COVID-19. The manufacturing and marketing approval was granted as part of an accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval's restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.