Glenmark Prescribed drugs, a research-led, international built-in pharmaceutical firm, on Wednesday mentioned the post-marketing surveillance (PMS) examine on Favipiravir (FabiFlu) has been concluded. The examine was carried out in over 1,000 sufferers of COVID-19, for which the outcomes confirmed no new security alerts or considerations with using Favipiravir, and already-known unwanted side effects similar to weak spot, gastritis, diarrhoea, vomiting and so on., had been discovered to be delicate in nature. The time for fever decision was 4 days, whereas time for medical remedy was 7 days.
Commenting on these findings, Mr. Alok Malik, Group Vice President & Head, India Formulations, mentioned, “This examine was essential because it examined the security and efficacy of FabiFlu in real-world settings, the place a number of variables can affect the outcomes. Regardless of these elements, the PMS examine demonstrated FabiFlu’s constant capability to offer symptomatic reduction and enhance medical outcomes in sufferers with delicate to reasonable COVID-19. It’s a step ahead each for Glenmark and the medical group, because it reinforces the oral antiviral’s a number of advantages in tackling the pandemic.”
On June 19, 2020, Glenmark turned the primary firm in India to obtain restricted emergency use approval from India’s drug regulator for Favipiravir (FabiFlu), making it the primary oral Favipiravir-approved remedy in India for the remedy of delicate to reasonable COVID-19. The approval was granted as a part of the accelerated approval course of, contemplating the emergency state of affairs of the COVID-19 outbreak in India.
This PMS examine continued to judge the security and efficacy of Favipiravir (FabiFlu) submit its launch out there. The typical age of sufferers within the examine was 40 years, with ladies comprising 40 per cent, whereas males 60 per cent of the examine inhabitants.
Hypertension (11%) and diabetes (8%) had been the 2 most typical comorbidities famous in these sufferers. Fever was current in all sufferers at baseline, adopted by cough (81%), fatigue (46.2%), and new lack of style (41%).