Drug agency Glenmark Pharmaceuticals on Tuesday stated interim information from its publish advertising surveillance research on anti-viral drug favipiravir in India helps its security and effectiveness in actual world settings with no new security issues for COVID-19 sufferers.
The research commenced in July 2020, aimed to judge security and efficacy of favipiravir in delicate to reasonable COVID-19 sufferers. As on date, a complete of 1,083 sufferers have been enrolled in the potential, open label, multicenter, single arm research, Glenmark stated in a regulatory submitting.
A complete of 13 websites throughout Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur and Trivandrum took half in the research, it added. Interim information offered by the corporate to the regulator reveals no new security indicators or issues with the usage of favipiravir and already-known unwanted effects which had been discovered to be delicate in nature, the submitting stated.
The time to fever decision was seen on day 3, whereas two-thirds of the sufferers achieved medical remedy on day 7.
“It is encouraging to notice that our interim information helps the protection 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.
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