As of 19 June 2020, Favipiravir has become the first repurposed drug approved for the oral treatment of COVID-19 infection in India. Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug for the treatment of mild to moderate COVID-19 patients after it received the Indian drug regulator Drug Controller General of India (DCGI) approval.
What was Favipiravir originally used for?
Favipiravir is an antiviral drug licensed in Japan in 2014 for the treatment of influenza. The recommended dosage for the flu is 1600 mg on the first day, followed by 600 mg from the second to the fifth day. For COVID-19, however, Glenmark’s study recommends the dose of 1800mg twice on the first day, followed by 800mg doses twice daily for 14 days.
Does Favipiravir weaken the immune system like other antivirals?
While there is no evidence yet that Favipiravir weakens the immune system in any way – more light can be shed on this once the Glenmark study is published – antiviral drugs, in general, do have an immunosuppressive reaction. This is primarily the reason why Favipiravir is a prescription drug that is provided to patients along with other immunomodulatory drugs to maintain immune function in the patient.
Can patients with comorbid conditions use Favipiravir?
Glenmark has claimed that Favipiravir can be administered in the recommended doses to patients who have underlying diseases or comorbidities like diabetes and heart disease. The company has, however, made it clear that Favipiravir will not be given to patients with severe kidney and liver diseases
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 spiraling 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.”
Cost of Favipiravir:
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.
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.
Mechanism of Action:
The mechanism of its actions is thought to be related to the selective inhibition of viral RNA-dependent RNA polymerase. Other research suggests that favipiravir induces lethal RNA transversion mutations, producing a nonviable viral phenotype. Favipiravir is a prodrug that is metabolized to its active form, favipiravir-ribofuranosyl-5′-triphosphate (favipiravir-RTP), available in both oral and intravenous formulations. Human hypoxanthine guanine phosphoribosyltransferase (HGPRT) is believed to play a key role in this activation process. Favipiravir does not inhibit RNA or DNA synthesis in mammalian cells and is not toxic to them.
(NOTE: FabiFlu is a prescription-based medicine and must be used only on doctor’s advice. We strongly recommend against self-medication)