Glenmark Pharmaceuticals Ltd. said it had started a post-marketing surveillance (PMS) study on FabiFlu to closely monitor its efficacy and safety in the 1,000 COVID-19 patients who have been prescribed the oral antiviral, as part of an open label, multi-centre, single-arm study.
Besides, the company has announced a price reduction of 27% for FabiFlu from ₹103 per tablet to ₹75 in India after it achieved higher yields and better scale, as both the API and formulations are made at its facilities in India.
Alok Malik, senior vice- president and head, India business, Glenmark Pharmaceuticals Ltd., 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 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 compared with 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,” he said.
Glenmark has also completed the phase three clinical trial with Favipiravir (FabiFlu) in mild to moderate COVID-19 patients in India. The trial results will be available shortly.
The company is also conducting an another Phase 3 clinical trial to evaluate the efficacy of two antiviral drugs viz. Favipiravir and Umifenovir as a combination therapy in moderate, hospitalised adult COVID-19 patients in India.
The combination study, which is called the FAITH trial, is looking to enrol 158 hospitalised patients of moderate COVID-19 in India. Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening the duration of virus shedding, facilitating early clinical cure and discharge of patients, the company said.