Glenmark announces 400 mg 'FabiFlu' for Covid-19 treatment

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.

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