Glenmark launches COVID-19 drug FabiFlu at Rs. 103 per tablet
Glenmark Pharmaceuticals Ltd. launched the antiviral drug favipiravir on Saturday for the treatment of mild to moderate cases of COVID-19. The Mumbai-based firm had received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday. The drug will reportedly be sold under the brand name FabiFlu at a price of Rs. 103 per tablet by June-end. Here are more details.
What is favipiravir?
Favipiravir is an antiviral medication that has been in use in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. The drug has shown clinical improvement of up to 88% in mild to moderate COVID-19 cases. It can be used for COVID-19 patients with co-morbid conditions such as diabetes and heart disease, Glenmark said.
FabiFlu will be launched commercially next week
FabiFlu is the first oral favipiravir-approved medication in India. It will be launched commercially next week and will likely be available across chemist outlets on a prescription basis by the end of June, The Print reported. The drug will be sold in a strip of 34 oral tablets of 200 mg each at a maximum retail price of Rs. 3,500 (Rs. 103 per tablet).
What is the recommended dose for the drug?
Glenmark said the recommended dose for FabiFlu is 1,800 mg twice daily on day one, and 800 mg twice daily subsequently up to day 14. The drug—being produced by Glenmark at its Baddi facility in Himachal Pradesh—will be available through both hospitals and retail.
'Approval for FabiFlu comes as COVID-19 cases spiral in India'
Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said in a statement, "This approval comes at a time when cases in India are spiraling like never before, putting tremendous pressure on our healthcare system." Till Saturday morning, India had reported 3,95,048 COVID-19 cases, after witnessing a record spike of 14,516 cases. The total tally includes 1,68,269 active cases, 2,13,830 recoveries, and 12,948 deaths.
Glenmark to work with government to make FabiFlu quickly accessible
Saldanha said, "Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country." Glenmark hopes that the availability of effective treatment will help reduce the pressure on the healthcare system, Saldanha said.
Approval granted as part of accelerated process
The Drugs Controller General of India (DCGI) had granted manufacturing and marketing approval for FabiFlu to Glenmark on Friday. The approval was granted as part of an accelerated approval process considering the coronavirus crisis in India. The approval's restricted use involves responsible medication usage wherein every patient is required to have signed informed consent before treatment initiation, Glenmark said.
'Favipiravir has wide therapeutic safety margin for COVID-19'
Sujesh Vasudevan—President India Formulations, Middle East and Africa, Glenmark Pharmaceuticals—said, "We chose to initiate work on favipiravir, as it has proven in-vitro activity against SARS-CoV-2 virus, which is the virus responsible for COVID-19." Vasudevan said, "Second is it has a wide therapeutic safety margin for COVID-19 at the dose that we administer," adding that FabiFlu has a huge benefit as an oral product.
