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Glenmark launches antiviral drug Favipiravir, trials show encouraging results in patients with mild to moderate COVID

IBEF:  June 22, 2020

Glenmark Pharmaceuticals launched an antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients.

The drug, Favipiravir, showed clinical evidence demonstrating encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage2 with clinical improvement noted across age groups 20 to >90 years.

According to the company’s official statement, “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 per cent in COVID-19 mild to moderate COVID-19 cases."

Glenmark, a research-led, integrated global pharmaceutical company received manufacturing and marketing approval from India’s drug regulator Drugs Controller General of India (DCGI), making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.

The active pharmaceutical ingredient (API) and the formulation for FabiFlu® was developed by Glenmark through its own in-house R&D team.

“This approval comes at a time when cases in India are spiralling like never before, putting a 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," said Mr Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd.

Mr Saldanha explained that FabiFlu® has demonstrated a positive response in mild to moderate COVID-19 patients during clinical trials. The drug is orally administered, making it as a more convenient treatment option over other intravenously administered medications. The company plans to work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country, he said.

Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. The drug has a unique mechanism of action where it is converted into an active phosphor-ribosylated form (favipiravir-RTP) in cells and is recognized as a substrate by viral RNA polymerase, thereby reducing RNA polymerase activity.

It can benefit patients exhibiting mild to moderate symptoms. The drug will be available as a prescription-based medication for Rs 103 (US$ 1.46)/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.

Glenmark had earlier announced that it is conducting another clinical trial to assess the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.

In India, as on June 20, the total number of COVID-19 cases crossed 4 lakh mark with a record fresh 15,790 cases in last 24 hours taking the total tally to 4,00,034. The death toll stood at 13,026. So far, a total of 2,13,830 patients have been cured of COVID-19 taking the recovery rate to 54.13 per cent. Currently, there are 1,68,269 active cases and all are under active medical supervision, the Government said in a statement. The number of government labs has been increased to 715 and private labs has been increased to 259 (A total of 974). In the last 24 hours, 1,89,869 samples were tested. The total number of samples tested thus far is 66,16,496, the Union Health Ministry said.

 

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.