Mumbai: Glenmark Pharmaceuticals on Wednesday announced that they have concluded post-marketing surveillance (PMS) study on Favipiravir (FabiFlu) in over 1000 COVID-19 patients, findings reinforce the drug’s safety and efficacy in real-world settings.

Glenmark’ claims the PMS study is the first and largest post-marketing study conducted in India on Favipiravir in mild to moderate COVID-19 patients. Thirteen sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part. The study was conducted in patients in line with the approved indication of the drug.

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The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1083 patients were enrolled in the prospective, open-label, multicentre, 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, diarrhoea, vomiting etc., were found to be mild. The time for fever resolution was 4 days, while the time for a clinical cure was 7 days.

The company stated that the study was initiated after Glenmark received restricted emergency use approval for Favipiravir (FabiFlu) for mild to moderate COVID-19.