New Delhi: Glenmark Pharmaceuticals has commenced a Post Marketing Surveillance (PMS) study to monitor the efficacy and safety of the oral antiviral FabiFlu, prescribed to nearly 1000 patients across the country.
"We expect the PMS study to shed more light on the drug's clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses. Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country," said Alok Malik, Senior Vice-President and Head - India business, Glenmark Pharmaceuticals Ltd.
The global pharmaceutical company has also announced a reduction in the price of the oral antiviral by 27 per cent in the country.
With the reduction, the new maximum retail price (MRP) of the drug has gone down to Rs 75 per tablet from the earlier Rs 103 per tab.
Price of FabiFlu in Russia is Rs 600/tab, Bangladesh Rs 350/tab, Japan Rs 378/tab, and China Rs 215/tab.
Officials said that the price reduction has been made possible, through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark Pharmaceuticals facilities in India, the benefits of which are being passed on to patients in the country.
Glenmark has successfully developed the active pharmaceutical ingredients and the formulations for FabiFlu through its own in house R&D team within the country, ensuring self-reliance with regard to long term production and manufacturing.
Also read: Glenmark Pharma cuts price of COVID-19 drug by 27% to Rs 75/tablet
The API is manufactured at the Gujarat production facility which is USFDA & MHRA-UK approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved.
Glenmark received manufacturing and marketing approval from India's drug regulator, Drug Controller General of India for FabiFlu, on June 20, making it the first oral Favipiravir approved medication in India for the treatment of mild to moderate COVID-19 patients. The manufacturing and marketing approval was granted as part of the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
Although Glenmark has already completed Phase 3 clinical trial with Favipiravir (FabiFlu) in mild to moderate COVID-19 patients in India, the company has also been conducting another Phase 3 clinical trial to evaluate the efficacy of two antiviral drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.
The combination study which is called the FAITH trial is looking to enrol 158 hospitalised patients of moderate category across India.
