Glenmark’s PMS study allays concerns on use of Favipiravir for Covid-19 treatment
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Glenmark’s PMS study allays concerns on use of Favipiravir for Covid-19 treatment

These were the findings of the Post Marketing Surveillance (PMS), study of Favipiravir (FabiFlu) on over 1000 patients

  • By IPP Bureau | September 15, 2021

There were no safety signals or concerns with the use of Favipiravir apart from the already known side effects such as weakness, gastritis, diarrhoea, vomiting etc., which were found to be mild in nature. The time for fever resolution was 4 days, while the time for the clinical cure was 7 days.

These were the findings of the Post Marketing Surveillance (PMS), study on Favipiravir (FabiFlu), conducted by Glenmark Pharmaceuticals. The study commenced in July 2020 to evaluate the safety and efficacy of the medicine in mild to moderate Covid-19 patients.

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 Thiruvananthapuram took part. The study was conducted in patients in line with the approved indication of the drug.

Commenting on these 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 Covid-19. 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."

On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India's drug regulator for 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 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 net loss of taste (41%).

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