India-based Glenmark Pharmaceuticals has secured regulatory approval for the manufacturing and marketing of antiviral drug Favipiravir under the brand name FabiFlu to treat mild to moderate Covid-19.
According to the company, Favipiravir demonstrated promising clinical evidence, with positive results in mild to moderate Covid-19 cases. Clinical improvement was observed in age groups of 20 to >90 years.
The drug is said to provide a rapid decrease in viral load within four days, along with quicker symptomatic and radiological improvement. Favipiravir demonstrated up to 88% of clinical improvement in patients with mild to moderate Covid-19.
The Favipiravir drug will be available as a 200 mg tablet at a maximum retail price of Rs 3,500 for a strip of 34 tablets.
It is a prescription-based medication with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14.
Requiring a total of 122 tablets costing around Rs 12566. Very high for the public to bear.
In India, Cipla and Hetero are also bringing Remdesivir very soon for commercial use....
But still as per many senior experienced doctors of AIIMS, Delhi - Till date we don't have evidence that a particular drug is effective, so we cannot call any drug game changer till then....
Although Favipiravir reduces viral load in mild to moderate cases.... it has not established it‘s effective efficacy yet.
*It is currently being tested in 18 clinical trials for Covid-19 and results from two studies have shown a positive outcome, while data from other trials is awaited. Glenmark has claimed that Favipiravir shows clinical improvements of up to 88 per cent in Covid-19, with rapid reduction in viral load by four days.
*Reference: Internet website
The Drug Controller General of India (DCGI) has granted permission to manufacture and sellGlenmark pharmaceuticals’ Favipiravir for Covid-19. The approval for Favipiravir 200 mg tablet has been given following the recommendation of special subject expert committee (SEC) on Covid-19. “Under an accelerated approval process at the Central Drugs Standard Control Organisation (CDSCO), the SEC has recommended the grant of permission to manufacture and market Glenmark’s Favipiravir, 200 mg tablet,”
"Glenmark Pharmaceuticals has received the manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug Favipiravir (FabiFlu®) for the treatment of mild to moderate Covid-19 patients in India," said the company in a statement.
The approval comes with a caveat that the company will have to submit a copy of the informed consent and report of the ongoing clinical trials within three months. The SEC has also recommended that the drug should be used with caution in patients with a history of abnormalities in metabolism of uric acid.
- Favipiraviris an RNA polymerase inhibitor.
- It is available in some Asian countries for treatment of influenza.
- A study of patients with non-severe disease (oxygen saturation >93%) revealed that the use of favipiravir was associated with faster viral clearance (median time to clearance 4 versus 11 days) and more frequent radiographic improvement (in 91% vs. 62% by day 14) compared with lopinavir-ritonavir. However, it must be noted that other therapies were administered in this non-randomized, open-label study, and the results should be interpreted with caution given potential confounders.
This is a good antiviral drug, however there is the problem of developing resistance with unknown epidemiology consequences.
Dr Anthony M. Kyriakopoulos MD/Ph.D. FIBMS
Remdesivir
Originally developed by US-based biopharma company Gilead Sciences, Remdesivir is an antiviral that was used for the treatment of Ebola and has been repurposed for treatment of Covid-19. Part of the World Health Organisation’s ongoing Solidarity Trials, Remdesivir received emergency use authorisation by the United States Food and Drug Administration (USFDA) on May 1.
This molecule is now approved by Govt of India.
Cipla Ltd has announced that the generic version of remdesivir will be sold under the brand name Cipremi. The medicine is in the form of lyophilized powder for injection (100 mg). Prices of the drug in the Indian market are yet to be announced by Cipla.
Please see the following RG links.
Article Experimental Treatment with Favipiravir for COVID-19: An Ope...
Article Favipiravir in Covid-19
Favipiravir is an antiviral drug, it can be used as a treatment of COVID-19 of varying severity but it can't decrease the rate of the disease.
Favipiravir, used to treat Covid-19 patients with mild to moderate symptoms, is witnessing a pricing war with more brands launching the oral antiviral tablet in the market
After Mumbai's Glenmark Pharma launched the drug here for Rs 103 per tablet in June, it revised the price recently to Rs 79 a tablet. Pune's Brinton Pharma got a nod for the tablets this week and they have chosen to price it for Rs 59 per tablet. Now another Mumbai based company Jenburkt Pharma has launched it for Rs 39 per tablet.
