Drug firm Glenmark Pharmaceuticals, on Wednesday, said its findings on anti-viral drug Favipiravir show "no new safety signals or concerns" in mild to moderate COVID-19 patients.
Announcing the completion of its Post Marketing Surveillance (PMS) study on Favipiravir in India, the pharma giant said, "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."
The PMS study was initiated 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, multicentre, single-arm study.
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 in the study which was conducted on patients in line with the approved indication of the drug.
Commenting on the findings, Alok Malik, Group Vice President & Head, India Formulations, said, "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."
On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from the country'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 the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
The 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 the evaluated patients.
Fever was present in all patients at baseline, followed by cough (81%), fatigue (46.2%), and new loss of taste (41%), the study revealed.
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