Drug maker Glenmark , on September 15, announced that it had found no new side effects in the post marketing surveillance (PMS) study on Favipiravir (FabiFlu) in over 1,000 COVID-19 patients.
The side effects reported are in line with the known safety profile of the drug, the company said.
Glenmark also said the time for fever resolution was four days while time for clinical cure was seven days.
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 company said.
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,"said Alok Malik, Group Vice President & Head, India Formulations.
"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 antivirals multiple benefits in tackling the pandemic,” Malik added.
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 an accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
Fabiflu has emerged as a money spinner for Glenmark, with the drug emerging as the top selling in April at the peak of COVID second wave the drug made Rs 352 crore accounting for over 2 percent of the total domestic pharma market sales.
Favipiravir, a broad-spectrum antiviral, was originally developed by Toyama Chemical Co, a subsidiary of Japanese drugmaker Fujifilm. The drug was approved in Japan in 2014, and repurposed for treating COVID-19, after studies in China and Russia have found the drug to be effective against treating mild and moderate COVID-19. But the use of Favipiravir has been controversial, with many medical experts questioning the benefit of the drug, when most mild COVID cases can resolve on their own.