Considering the emergency situation of the COVID-19 outbreak in India, Manufacturing and marketing approval granted as part of accelerated approval process.
The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation
Favipiravir shows clinical improvements of up to 88% in COVID-19, with rapid reduction in viral load by 4 days
Clinical improvement noted across age groups 20 to >90 years, including in patients with co-morbid conditions like diabetes and heart disease suffering from mild to moderate COVID-19
FabiFlu is the first oral Favipiravir-approved medication in India for the treatment of COVID-19, it said in a statement.
“This drug was already being used in Japan for influenza. They have been using it in COVID-19 patients also. Even China was using it and Russia had also given permission in May to use it. Antiviral drugs like Remdesivir and Favipiravir are not specific to COVID-19 but were being used for influenza,” said Dr Vikas Maurya, Director, Department of Pulmonology and Sleep Disorders, Fortis Hospital, Shalimar Bagh.
He said studies found that there was some benefit of Favipiravir in COVID-19 treatment and that is why it has now been launched in India as well.
Dr Maurya said with COVID-19 cases rising, the launching of the drug comes as a relief.
“This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said in the statement.
Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms, Glenmark added.
It offers rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement.
Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases, it said.