NEW DELHI: Glenmark Pharmaceuticals on Wednesday said it did not find any new side effects of its antiviral Favipiravir, or Fabiflu, during its post marketing surveillance (PMS) study in India. The drug is used for covid management.
The 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, multi-centre, 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 said in a statement.
Glenmark’s study, the company claimed, is the first and the largest post marketing study conducted in India - across 13 sites in both government and private institutions in Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum.
“This study was crucial as it examined the safety and efficacy of FabiFlu in real-world settings, where multiple variables can impact the results…the PMS study demonstrated FabiFlu’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate covid- 19," said Alok Malik, group vice president and head, India Formulations.
In June last year, Glenmark received restricted emergency use approval from India's drug regulator for Favipiravir, making it the first oral medication in the country for the treatment of mild to moderate covid-19.
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%), the company said.
