Glenmark Pharmaceuticals concludes post-marketing surveillance on Favipiravir in 1000 COVID-19 patients
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.
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.