Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, on Wednesday said the post-marketing surveillance (PMS) study on Favipiravir (FabiFlu) has been concluded. The study was conducted in over 1,000 patients of COVID-19, for which the results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhoea, vomiting etc., were found to be mild in nature. The time for fever resolution was 4 days, while time for clinical cure was 7 days.
Commenting on these findings, Mr. Alok Malik, Group Vice President & Head, India Formulations, said, “This study was crucial as it examined the safety and efficacy of FabiFlu in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID-19. It is a step forward both for Glenmark and the medical community, as it reinforces the oral antiviral’s multiple benefits in tackling the pandemic.”
On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for Favipiravir (FabiFlu), making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The approval was granted as part of the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
This PMS study continued to evaluate the safety and efficacy of Favipiravir (FabiFlu) post its launch in the market. The average age of patients in the study was 40 years, with women comprising 40 per cent, while men 60 per cent of the study population.
Hypertension (11%) and diabetes (8%) were the two most common comorbidities noted in these patients. Fever was present in all patients at baseline, followed by cough (81%), fatigue (46.2%), and new loss of taste (41%).