The Glenmark Pharmaceuticals' post-marketing surveillance (PMS) study has shown no safety concerns with the use of Favipiravir (FabiFlu®[?]) in India for COVID-19 infection.
Favipiravir (FabiFlu®[?]) was used to treat patients with moderate to mild COVID-19 infection.
According to the research-led and global integrated pharmaceutical company, the PMS study was done on 1083 patients at multiple centres. The purpose of the study was to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients.
The results showed no safety concerns with the use of Favipiravir, the statement issued by Glenmark Pharmaceuticals said.
"Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhoea and vomiting, were found to be mild in nature. The time for fever resolution was four days, while the time for the clinical cure was seven days, the statement issued read.
"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," it stated.
Commenting on the study Alok Malik, Group Vice President and Head of 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 COVID19. It is a step forward for both Glenmark and the medical community, as it reinforces the oral antiviral's multiple benefits in tackling the pandemic."
Glenmark Pharmaceuticals is 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.
India for the treatment of mild to moderate COVID-19.
( With inputs from ANI )
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