Glenmark Pharmaceuticals, a research-led, world built-in pharmaceutical firm, on Wednesday introduced the profitable completion of its Post-Marketing Surveillance (PMS) research on Favipiravir in India.
A press release issued Wednesday stated the PMS research commenced in July 2020 to judge the safety and efficacy of Favipiravir in mild to average Covid-19 sufferers. A complete of 1,083 sufferers have been enrolled within the potential, open-label, multicenter, single-arm research. Results confirmed no new safety signals or considerations with the use of Favipiravir, and already-known side effects akin to weak point, gastritis, diarrhea and vomiting have been discovered to be mild in nature. The time for fever decision was 4 days, whereas the time for a scientific treatment was seven days.
Glenmark’s PMS research is the primary post-marketing research carried out in India on Favipiravir in mild to average Covid-19 sufferers.
Thirteen websites – each authorities and personal establishments – throughout Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvananthapuram, took half. The research was carried out in sufferers in line with the authorised indication of the drug.
On June 19, 2020, Glenmark turned the primary firm in India to obtain restricted emergency use approval from India’s drug regulator for Favipiravir, making it the primary oral Favipiravir-approved treatment in India for the therapy of mild to average Covid-19. The approval was granted as half of an accelerated approval course of, contemplating the emergency scenario of the Covid-19 outbreak in India.
This PMS research continued to judge the safety and efficacy of Favipiravir after its launch out there. The common age of sufferers within the research was 40 years with girls comprising 40 per cent of the research inhabitants and males 60 per cent. Hypertension (11 per cent) and diabetes (8 per cent) have been the 2 commonest comorbidities famous in these sufferers.
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