Glenmark’s FabiFlu gets DCGI nod as Covid-19 drug, in stores next week: All you need to know
Amid the raging coronavirus pandemic, which has spread to more than 185 countries globally, India-based Glenmark Pharmaceuticals has launched antiviral drug Favipiravir, to be sold under the brand name FabiFlu, for the treatment of patients with mild to moderate Covid-19 symptoms.
FabiFlu is the first oral Favipiravir-approved medication for the treatment of Covid-19, the company said in a statement after it received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday. The drug, called FabiFlu, will be marketed in some north Indian states soon.
“This approval comes at a time when Covid-19 cases in India are spiralling like never before, putting tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said.
Bringing some relief for Covid-19 patients, even as the country reported an all-time high of 14,516 new coronavirus cases on Saturday, the drug will soon be available in hospitals and stores in a pack of 34 oral tablets at moderately affordable prices.
Here’s all you need to know about FabiFlu:
* The medicine has produced up to 88% improvement in mild to moderate coronavirus patients during clinical trials, making it the first oral antiviral drug available under emergency use authorization to treat Covid-19 patients in India.
*It will be available across the country by early next week, the company said on Saturday. The drug that has been indigenously manufactured will be available for sale both in hospitals and retail pharmacies, and is to be given under strict medical supervision. It is not an over-the-counter drug, and its sale will only be allowed on possession of a valid medical prescription by a doctor.
* It will be sold in a pack of 34 oral tablets of 200 mg each at a cost of Rs 3,500 and the cost of the 14-day treatment will be an estimated Rs 14,000.
* Each tablet of 200 mg will cost Rs103.
* The dosage will be 3,600 mg on day one, and 1,600 mg from day two onwards for a maximum duration of 14 days.
* Every patient must give his or her informed consent before starting treatment with the drug.
* The medicine can be administered to coronavirus patients between the age group of 18 and 75.
* On Friday, Glenmark Pharmaceuticals had announced it has received approval from India’s central drug regulator for manufacturing and marketing FabiFlu as an oral antiviral drug to treat mild to moderate Covid-19 patients in the country.
* The company has already started production of the drug. In some states, that are closer to the pharma company’s manufacturing unit in Baddi (Himachal Pradesh) the drug will be rolled out by the end of this week and across India it will be supplied by early next week, Sujesh Vasudevan, president, India formulations, Middle East and Africa, at Glenmark said.
* Favipiravir has been used in Russia, Japan and China to treat such patients and has proved successful, according to the company.
* Random clinical trials in India have been conducted on 150 Covid-19 patients at about 11 hospitals, who were diagnosed coronavirus positive through a reverse transcriptase-polymerase chain reaction (RT-PCR) test. Of them, 90 were mild cases and 60 were moderately sick patients.
* The drug, however, is not recommended for people suffering from severe kidney or liver ailments, pregnant and lactating women.
* Currently, the company’s priority is the Indian market, but at a later stage it is also mulling the possibility of exporting the drug.
*Favipiravir can be used in Covid-19 patients with comorbid conditions such as diabetes and heart disease with mild to moderate Covid-19 symptoms. It offers rapid reduction in viral load within four days, and provides faster symptomatic and radiological improvement. Most importantly, Favipiravir has shown clinical improvement of up to 88% in Covid-19 mild to moderate patients, the company has said.
At present, the injectible antiviral drug Remdesivir and immunosuppressant Tocilizumab are part of India’s treatment protocol, under restricted and off-label use, for Covid-19 patients in the country.