Rohit Shishodia

Post-marketing surveillance (PMS) study on Favipiravir (Fabiflue) conducted by Glenmark has found no new safety signals or concerns with the use of the drug on mild to moderate COVID-19 patients.

“Already known side effects such as weakness, gastritis, diarrhea, and vomiting were found to be mild. The time for resolution was four days while time for the clinical cure was seven days,” Glenmark said in a statement on September 15, 2021.

The pharma company stated that the PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID patients.

A total of 1,083 patients were enrolled in the prospective, open-label, multicenter, and single-arm study.

The study was carried out in government and private hospitals in 13 sites.

“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 COVID-19,” the Group Vice President and Head of India Formulations, Alok Malik said.

“It is a step forward for Glenmark and the medical community, as it reinforces the oral antiviral’s multiple benefits in tackling the pandemic,” he added.