Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects like weakness, gastritis, diarrhoea, vomiting etc were found to be mild in nature.
Drug firm Glenmark Pharmaceuticals on Wednesday said it has successfully completed its post-marketing surveillance study on Favipiravir in India. The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients, Glenmark said in a statement.
Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects like weakness, gastritis, diarrhoea, vomiting etc were found to be mild in nature. The time for fever resolution was 4 days, while the time for the clinical cure was 7 days, it added.
The study was conducted at thirteen sites – both government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum. It was conducted in patients in line with the approved indication of the drug, Glenmark said. The average age of patients in the study was 40 years, with women comprising 40 per cent and 60 per cent men, it added.
“This study was crucial as it examined the safety and efficacy of FabiFlu in real-world settings, where multiple variables can impact the results,” Glenmark Pharmaceuticals, Group Vice President & Head, India Formulations, Alok Malik said.
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, he added.
On June 19, 2020, Glenmark received restricted emergency use approval from India’s drug regulator for Favipiravir for the treatment of mild to moderate COVID-19, the company said. Shares of Glenmark Pharmaceuticals were trading at Rs 535.85 per scrip on BSE, up 0.81 per cent from its previous close.