Pune: Glenmark Pharmaceuticals has introduced 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.
Dr Monika Tandon, Vice President and Head of Clinical Development said, “Glenmark is the first company in India to have received the regulator’s approval for 400 mg dosage form. 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.”
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, multicentre, single-arm study. Glenmark is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antiviral 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.