Study finds no new safety signals with use of Favipiravir, side effects mild

A statement issued Wednesday said the PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients.

Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, on Wednesday announced the successful completion of its Post-Marketing Surveillance (PMS) study on Favipiravir in India.

A statement issued Wednesday said the PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients. A total of 1,083 patients were enrolled in the prospective, open-label, multicenter, single-arm study. Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhea and vomiting were found to be mild in nature. The time for fever resolution was four days, while the time for a clinical cure was seven days.

Glenmark’s PMS study is the first post-marketing study conducted in India on Favipiravir in mild to moderate Covid-19 patients.

Thirteen sites – both government and private institutions – across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvananthapuram, took part. The study was conducted in patients in line with the approved indication of the drug.

On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for Favipiravir, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate Covid-19. The approval was granted as part of an accelerated approval process, considering the emergency situation of the Covid-19 outbreak in India.

This PMS study continued to evaluate the safety and efficacy of Favipiravir after its launch in the market. The average age of patients in the study was 40 years with women comprising 40 per cent of the study population and men 60 per cent. Hypertension (11 per cent) and diabetes (8 per cent) were the two most common comorbidities noted in these patients.

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