New Delhi: Glenmark Pharmaceuticals has announced that it has commenced a Post Marketing Surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 COVID patients that are prescribed with the oral antiviral.
Further, Glenmark has announced a price reduction of 27 per cent for FabiFlu. The new MRP is Rs 75 per tab from the earlier Rs 103 per tab.
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’s facilities in India, the benefits of which are being passed on to patients in the country.
Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team within the country, ensuring self-reliance with regard to long term production and manufacturing.
Commenting on these developments, Alok Malik, Senior Vice President & Head – India business, Glenmark Pharmaceuticals said, “We expect this post-marketing surveillance 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.”
Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu (API and formulations), Glenmark has managed to keep the pricing of FabiFlu lower as compared to its price in other countries.
FabiFlu in India was originally launched at Rs 103 per tablet, while, its price in Indian Rupees is higher in the remaining countries like Rs 600 in Russia, Rs 378 in Japan, Rs 350 in Bangladesh and Rs 215 in China.
On June 20, Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.
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. The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.