Glenmark has become the first pharmaceutical company in India to receive regulatory approval for oral antiviral favipiravir, for the treatment of mild to moderate COVID-19. The company has received manufacturing and marketing approval from India's drug regulator, making FabiFlu the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, announced the launch of antiviral drug Favipiravir (brand name FabiFlu) for the treatment of mild to moderate COVID-19 patients.
Favipiravir is backed by strong clinical evidence
Favipiravir is backed by strong 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 across age groups 20 to more than 90 years.
FabiFlu tablets can be used by patients with prior conditions like diabetes and heart disease as well
Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days, and provides faster symptomatic and radiological improvement. Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.
Glenmark first pharmaceutical company in India to receive approval
Glenmark filed the product for a clinical trial with India's drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, "This approval comes at a time when cases in India are spiralling like never before, putting tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu will considerably help assuage this pressure and offer patients in India a much needed and timely therapy option."
He added, "FabiFlu has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country."
Favipiravir is approved in Japan since 2014 for the treatment of novel 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 recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. The drug will be available as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
The dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days.
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 hospitalized adult COVID-19 patients in India.
FabiFlu Big Takeaways: The Oral Antiviral Favipiravir, used for the treatment of mild to moderate COVID-19
Note: Glenmark is the first Indian pharmaceutical company to get the DCGI (India Drug Body) approval to produce tablets used in treating coronavirus patients.
NOTE: FabiFlu is a prescription-based medicine and must be used only on doctor's advice. We strongly recommend against self-medication)
(With inputs from PTI/under an arrangement from PR Newswire)