Glenmark Pharmaceuticals to introduce a 400 mg version of oral antiviral FabiFlu for treatment of mild to moderate Covid-19 in India. The higher strength will improve patient compliance and experience by 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 company said without disclosing the price. The 200 mg of FabiFlu costs Rs 75 per tablet. The higher strength of 400 mg is expected to be competitively priced and will be available in a week’s time.
The 200 mg dosage of FabiFlu required patients to take 18 tablets on Day 1, 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 and thereafter 2 tablets twice a day from Day 2 till 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,” Monika Tandon, vice-president & head, clinical development, global specialty/branded portfolio, Glenmark Pharmaceuticals, said. “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.”
Glenmark has also commenced a post-marketing surveillance 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. The company 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 which is called the FAITH trial is looking to enroll 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 duration of virus shedding, facilitating early clinical cure and discharge of patients.