Effective oral antiviral, FabiFlu gets govt. approval for COVID treatment in India

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With the nation steadily breaking the record number of infections, nearly every two-days, India-based pharmaceutical brand Glenmark has got DGCI approval for manufacturing and selling an effective oral anti-viral drug for COVID-19 patients in India.

The drug-makers announces the launch of Favipiravir – to be available in hospitals and pharmacies – is an oral antiviral and will be made available for the treatment of mild to moderate symptoms of COVID-19 patients in India.

The antiviral will be sold under the branding of FabiFlu which the company says in a statement is the first oral antiviral that gets a nod from India’s drug regulator for the treatment of coronavirus.

“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,” Chairman and Managing Director of Glenmark Pharmaceuticals Ltd, Mr. Glenn Saldanha told in a statement.

What is FabiFlu?

FabiFlu is an antiviral that is composed of ‘Favipiravir;’ a drug developed in-house through Genmark’s R&D. The drug has been successfully used to treat similar cases in Japan, Russia and China already. In clinical studies, it has promised improvement in mild to moderate COVID-19 patients of up to 88%. Dosage of the drug in the test resulted in ‘rapid drop’ in viral load within 4 days, the company says in a statement.

Effective oral antiviral, FabiFlu gets govt. approval for COVID treatment in India

The clinical testing showed the drug improved conditions in patients ranging from 20 to 90-years of age, including a patient with accompanying life-threatening illnesses like diabetes and heart ailment plus COVId-19. Some of the other information about the drug’s use and availability are:

  • FabiFlu must be used with consent from the patient
  • The drug is not an over-the-counter medication and will need a prescription for purchase
  • The recommended dose will be 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14
  • A 200mg tab ill be priced at Rs.103
  • The drug will be sold in a pack of 34 oral tabs (200mg each) priced at Rs 3,500 and 14-day treatment will cost Rs. 14k
  • People suffering from liver, kidney ailments, and lactating or pregnant women will not use this drug

The company has reportedly started manufacturing the drug and will be available in some Indian states earlier than the other. Overall, by early next week, the company says it should be available early next week, Hindustan Times reports.