Indian government approves FabiFlu for mild to moderate COVID-19 patients.- Glenmark Pharma

Glenmark Pharmaceuticals announced the launch of antiviral drug FabiFlu (favipiravir) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu the first oral Favipiravir-approved medication in India for the treatment of COVID-19.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load by 4 days and provides faster symptomatic and radiological improvement. Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.

Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team. Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase III clinical trial on mild to moderate COVID-19 patients. Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. The drug will be available as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.