Mumbai : Indian Pharmaceutical major Glenmark on Wednesday announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India. 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 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 in nature. The time for fever resolution was 4 days, while time for clinical cure was 7 days.
Glenmark’s 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.
“This study was crucial as it examined the safety and efficacy of FabiFlu® in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu®’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID19. It is a step forward both for Glenmark and the medical community, as it reinforces the oral antiviral’s multiple benefits in tackling the pandemic” Mr. Alok Malik, Group Vice President & Head, India Formulations, said.
On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for Favipiravir (FabiFlu®), 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 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 (FabiFlu®) post its launch in the market. The average age of patients in the study was 40 years, with women comprising 40%, while men 60% of the study population. Hypertension (11%) and diabetes (8%) were the two most common comorbidities noted in these patients. Fever was present in all patients at baseline, followed by cough (81%), fatigue (46.2%), and new loss of taste (41%).