Drug firm Glenmark Pharmaceuticals on Tuesday said interim data from its post marketing surveillance study on anti-viral drug favipiravir in India supports its safety and effectiveness in real world settings with no new safety concerns for COVID-19 patients.
The study commenced in July 2020, aimed to evaluate safety and efficacy of favipiravir in mild to moderate COVID-19 patients. As on date, a total of 1,083 patients have been enrolled in the prospective, open label, multicenter, single arm study, Glenmark said in a regulatory filing.
A total of 13 sites across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur and Trivandrum took part in the study, it added. Interim data presented by the company to the regulator reveals no new safety signals or concerns with the use of favipiravir and already-known side effects which were found to be mild in nature, the filing said.
The time to fever resolution was seen on day 3, while two-thirds of the patients achieved clinical cure on day 7.
“It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu in real-world settings,” Glenmark Pharmaceuticals Group Vice President and Head, India Formulations, Alok Malik said. On June 19, 2020, Glenmark received restricted emergency use approval from India’s drug regulator for FabiFlu for the treatment of mild to moderate COVID-19.