Glenmark to launch FabiFlu (400 mg) for COVID-19 treatment

Glenmark Pharmaceuticals announced that it will introduce a 400 mg version of oral antiviral FabiFlu, for the treatment of mild to moderate COVID-19 in India. The company informs that the higher strength will improve patient compliance and experience, by effectively reducing the number of tablets that patients require per day.

The 200 mg dosage of FabiFlu required patients to take 18 tablets on Day 1 (nine in the morning and nine in the evening), followed by eight tablets each day thereafter for a maximum of 14 days. With the new 400 mg version, patients need to consume nine tablets on Day 1 (4.5 in the morning and 4.5 in the evening), and thereafter two tablets twice a day from Day 2 till the end of the course.

Dr Monika Tandon, Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals, said, “Being the first company to launch favipiravir in India, we continue to innovate and seek new treatment options for COVID-19 patients. Introducing this higher strength of FabiFlu is in line with these efforts to ensure a smoother experience for patients, by reducing their daily pill burden.”

“The 200 mg dosage of FabiFlu was developed in line with global formulations of the drug favipiravir, which had similar strength. The 400 mg version is a result of Glenmark’s own R&D efforts to improve the treatment experience for patients in India,” she added.

Glenmark has also commenced post-marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in a large pool of patients prescribed with the oral antiviral favipiravir, as part of an open label, multicenter, single-arm study. It is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalised adult COVID-19 patients in India. The combination study, 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.