Glenmark Pharmaceuticals, a research-led global pharmaceutical company, on Thursday announced that it is set to introduce a 400 mg version of oral antiviral – FabiFlu — for the treatment of mild to moderate COVID-19 in India.
It was the first Indian company to commercially launch an antiviral drug – Favipiravir with brand name FabiFlu – for the treatment COVID-19 patients. The company received marketing and manufacturing approval from the Drug Controller General of India and launched the product in the Indian market on June 20.
According to the company, the higher strength will improve patient compliance and experience, by effectively reducing the number of tablets that patients require per day.
Earlier, 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.
A higher pill burden has been associated with lower adherence to therapy, the latter affecting viral suppression and overall treatment outcomes. Reducing the pill burden has also been a demand from doctors and patients to enable adherence, the company said.
“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,” Glenmark Pharmaceuticals added.
Explaining the significance of this development, Monika Tandon, Vice President and Head, Clinical Development of Glenmark Pharmaceuticals Limited 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.”
She added, “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.”
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.
It is also conducting another Phase III 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.