The antiviral offers broad-spectrum RNA virus coverage with a clinical improvement noted in the 20 to> 90 age group (REUTERS / Dado Ruvic / Illustration / File Photo)
In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led and integrated global pharmaceutical company, today announced the launch of the antiviral drug Favipiravir (brand FabiFlu) for the treatment of patients with mild COVID-19 to moderate.
Glenmark received manufacturing and marketing approval from the Indian drug regulator, making FabiFlu the first oral medication approved by Favipiravir in India for the treatment of COVID-19.
Favipiravir is supported by solid clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted in age groups 20 to> 90 years.
Favipiravir can be used in COVID-19 patients with comorbid conditions such as diabetes and heart disease with mild to moderate symptoms of COVID 19. It offers a rapid reduction in viral load in 4 days and provides faster symptomatic and radiological improvement. Most importantly, Favipiravir has shown a clinical improvement of up to 88% in cases of mild to moderate COVID-19.
Glenmark successfully developed the Active Pharmaceutical Ingredient (API) and FabiFlu formulation through its own in-house R&D team.
Glenmark presented the product for a clinical trial with the Indian drug regulator DCGI and became the first pharmaceutical company in India to receive approval to conduct a phase clinical trial in patients with mild to moderate COVID-19.
Commenting on the importance of this development, Mr. Glenn Saldanha, President and Managing Director of Glenmark Pharmaceuticals Ltd., said: “This approval comes at a time when cases in India are spiraling like never before, exerting enormous pressure on our health system. We hope that the availability of an effective treatment like FabiFlu will greatly help to alleviate this pressure and offer patients in India a much-needed and timely therapy option. ”
He added: “FabiFlu has shown an encouraging response in patients with mild to moderate COVID-19 during clinical trials. Additionally, it is administered orally, thus serving as a more convenient treatment option than other intravenously administered medications. Glenmark will work closely with the government and the medical community to make FabiFlu quickly accessible to patients across the country. ”
Favipiravir has been approved in Japan since 2014 for the treatment of new or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and is recognized as a substrate by viral RNA polymerase, thereby inhibiting the activity of RNA polymerase.
Most patients with mild to moderate symptoms can benefit from the use of FabiFlu. The drug will be available as a prescription drug for INR 103 / tablet, with a recommended dose of 1800 mg twice daily on day 1, followed by 800 mg twice daily until day 14.
Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals, Favipiravir and Umifenovir, as a combination therapy in moderate adult patients hospitalized with COVID-19 in India.
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