New Delhi, August 7
Glenmark Pharmaceuticals, a research-led international pharmaceutical firm, on Thursday introduced that it’s set to introduce a 400 mg model of oral antiviral – FabiFlu — for the remedy of gentle to average Covid-19 in India.
It was the primary Indian firm to commercially launch an antiviral drug – Favipiravir with model identify FabiFlu – for the remedy Covid-19 sufferers. The firm obtained advertising and marketing and manufacturing approval from the Drug Controller General of India and launched the product within the Indian market on June 20.
According to the corporate, the upper power will enhance affected person compliance and expertise, by successfully lowering the variety of tablets that sufferers require per day.
Earlier, the 200 mg dosage of FabiFlu required sufferers to take 18 tablets on Day 1, adopted by eight tablets every day thereafter for a most of 14 days.
A better tablet burden has been related to decrease adherence to remedy, the latter affecting viral suppression and general remedy outcomes. Reducing the tablet burden has additionally been a requirement from medical doctors and sufferers to allow adherence, the corporate mentioned.
“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 importance of this improvement, Monika Tandon, Vice President and Head, Clinical Development of Glenmark Pharmaceuticals Limited mentioned, “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 additionally commenced a Post Marketing Surveillance (PMS) research on FabiFlu to intently monitor the efficacy and security of the drug in a big pool of sufferers prescribed with the oral antiviral Favipiravir, as a part of an open label, multicentre, single arm research.
It can also be conducting one other Phase III scientific trial to judge the efficacy of two antiviral medication Favipiravir and Umifenovir as a mixture remedy in average hospitalized grownup Covid-19 sufferers in India.
The mixture research which known as the FAITH trial is seeking to enrol 158 hospitalized sufferers of average Covid-19 in India. Early remedy with mixture remedy will probably be evaluated for security and efficacy as it’s rising as an efficient method in shortening length of virus shedding, facilitating early scientific treatment and discharge of sufferers.