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 one (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 will now have a more relaxed dosage regimen, with nine tablets required on Day one (4.5 in the morning and 4.5 in the evening), and thereafter two tablets twice a day from Day two till the end of the course.
"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," said Dr Monika Tandon, Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd, explaining the significance of this development.
"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 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 antiviral Favipiravir, 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 enroll 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 the duration of virus shedding, facilitating early clinical cure, and discharge of patients.
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( With inputs from ANI )