Glenmark Pharmaceuticals has announced today the successful conclusion of its Favipiravir (FabiFlu®) post marketing surveillance (PMS) in India study, which has been carried out under the research of a globally integrated pharmaceutical company. The PMS study in mild to moderate COVID-19 patients began in July 2020 to evaluate the safety and effectiveness of Favipiravir. In total, 1083 patients participated in the future open-label, multicenter, and single arm study. Results showed no new safety signals or concerns with use of favipiravir, and already known adverse consequences were found to be mild in nature, such as weakness, gastritis, diarrhoea, vomiting etc. The time for fever resolution was 4 days, while time for clinical cure was 7 days.
Glenmark’s PMS study is the first and largest post marketing study conducted in India on Favipiravir in mild to moderate COVID-19 patients. Thirteen sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part. The study was conducted in patients in line with the approved indication of the drug.
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.”
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Glenmark concludes post marketing surveillance (PMS) study on Favipiravir (FabiFlu®) in 1000+ COVID-19 patients, findings reinforce the drug’s safety and efficacy in real world settings.
Glenmark’s PMS study is the first and largest post marketing study conducted in India on Favipiravir in mild to moderate COVID-19 patients.
The study was initiated after Glenmark received restricted emergency use approval for Favipiravir (FabiFlu®) for mild to moderate COVID-19
Results show no new safety signals or concerns till date and side effects reported are in line with known safety profile of the drug
Glenmark is the only organization in India to conduct a Phase 3 study and the first to receive restricted emergency use approval for Favipiravir (FabiFlu®)