The drug manufacturer Glenmark, on September 15, announced that it had found no new adverse effects in the post marketing surveillance (PMS) study conducted on Favipiravir (FabiFlu) in more than 1,000 COVID-19 patients.
The reported side effects are in line with the well-known safety profile of the drug, the company said.
Glenmark also said that the duration of fever relief was four days and the duration of treatment was seven days.
The PMS study began in July 2020 to test the safety and efficacy of Favipiravir in mild and moderate COVID-19 patients.
A total of 1083 patients enrolled in what will be a, open-label, multi-site, one-arm reading.
“The results showed no new signs of safety or concern about Favipiravir use, and the already known side effects such as weakness, diarrhea, diarrhea, vomiting, etc., were found to be mild by nature,” the company said.
Glenmark’s PMS study is the first and largest marketing study conducted in India at Favipiravir for COVID-19 patients in middle and middle class.
Thirteen sites – both public and private institutions – in Mumbai, Bangalore, Hyderabad, Nashik, Nagpur and Trivandrum participated. The study was performed on patients in accordance with the approved dosage of the drug.
“This study was invaluable as it examined the safety and effectiveness of FabiFlu in real-world areas, where many variables could affect outcomes,” said Alok Malik, Vice President of Group & Head, India Formulations.
“Despite these factors, PMS research has shown FabiFlu consistency
the ability to provide significant relief and improve clinical outcomes in patients with mild to moderate COVID19. It is a step forward in both Glenmark and health care, as it strengthens the oral contraceptives for the many benefits of dealing with the epidemic, ”said Malik.
On June 19, 2020, Glenmark became the first company in India to obtain an approved drug use approved by the Indian drug regulator Favipiravir (FabiFlu), making it the first oral drug approved by Favipiravir in India for mild and moderate COVID-19 treatment. . Permission has been granted as part of a speedy accreditation process, given the emergency situation of the COVID-19 outbreak in India.
Fabiflu emerged as Glenmark’s money spinner, and the drug emerged as the best-selling drug in April during the second wave of COVID drug making Rs 352 crore accounting for more than 2 percent of the gross domestic product market sales.
Favipiravir, a comprehensive antiviral, was originally developed by Toyama Chemical Co, a company owned by Japanese drugmaker Fujifilm. The drug was approved in Japan in 2014, and then returned to the treatment of COVID-19, after studies in China and Russia have found the drug to be effective in treating mild and moderate COVID-19. However, the use of Favipiravir has been controversial, with many medical professionals questioning the benefits of the drug, which many COVID cases cannot resolve on their own.