Glenmark reports positive interim data from PMS study on Favipiravir
Glenmark Pharmaceuticals said that interim data from its post marketing surveillance (PMS) study on Favipiravir (FabiFlu) in India supports the Covid-19 drug’s safety and effectiveness in real world settings.
Besides, no new safety signals or concerns were seen in the 503 Covid-19 patients who are part of the PMS study.
The time taken for fever to subside was noted on day 3, while two-third of the patients included in the interim data achieved clinical cure on day 7.
The average age of patients was 40 years with women making up 40% and men being 60% of the study population. The most common age group in the participants was 30-45 years.
Launched in July 2020, the PMS study was taken up to assess the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients.
Glenmark Pharmaceuticals reports positive interim data from PMS study on Covid-19 drug Favipiravir. Image courtesy of visuals3Dde from Pixabay.
According to Glenmark Pharmaceuticals, the PMS study is the first and large post marketing study being held in India on Favipiravir in mild to moderate Covid-19 patients. So far, 1083 patients have been enrolled in the open label, multicenter, single arm study.
The PMS study is being held across 13 sites, which includes both government and private institutions across Mumbai, Bengaluru, Hyderabad, Nagpur, Nashik, and Trivandrum.
Alok Malik – Group Vice President and Head, India Formulations, Glenmark Pharmaceuticals said: “It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu in real-world settings. Since its launch last year, FabiFlu has provided immense relief to millions of patients in India and the world, while also reducing the overall burden on healthcare infrastructure.
“We will soon submit the final study findings to the regulator and continue to deliver FabiFlu’s multiple benefits to patients all over.”
In June 2020, Glenmark Pharmaceuticals became the first company in India to secure restricted emergency use approval from the Indian drug regulator for FabiFlu for the treatment of mild to moderate Covid-19.
The approval was given as part of accelerated approval process owing to the emergency situation of the Covid-19 outbreak in the country.