Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical
company, today 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 higher strength will improve patient compliance
and experience, by effectively reducing the number of tablets that patients require per day.
A higher pill burden has been associated with lower adherence to therapy, the latter affecting viral
suppression and overall treatment outcomes. Also reducing the pill burden has been a demand from doctors
and patients to enable adherence. 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 8 tablets each day thereafter for a
maximum of 14 days. With the new 400 mg version, patients will now have a more relaxed dosage
regimen, with 9 tablets required on Day 1( 4.5 in the morning and 4.5 in the evening), and thereafter 2
tablets twice a day from Day 2 till end of the course.
Explaining the significance of this development, Dr. Monika Tandon, Vice President & Head, Clinical
Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., 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
treatment experience for patients in India,” she added.
Glenmark has also commenced a 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
antiviralFavipiravir, as part of an open label, multicenter, single arm study.Glenmark 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 hospitalized adult COVID-19 patients in India. The combination study
which is called the FAITH trial is looking to enrol 158 hospitalized 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 duration of virus shedding, facilitating early clinical cure and
discharge of patients.
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About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led
