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Glenmark plans to launch antiviral drug for Covid-19 in next few days
The drug, marketed under the brand name FabiFlu, will be marketed in some north Indian states by Saturday evening.
Glenmark Pharmaceuticals Limited plans to launch its anti-viral drug Favipiravir, which produced improvement of up to 88% in mild to moderate coronavirus disease cases during clinical trials, across India by early next week, the company said on Saturday, making it the first oral antiviral available under emergency use authorisation to treat Covid-19 patients in the country.
The drug, marketed under the brand name FabiFlu, will be marketed in some north Indian states by Saturday evening. Available in a pack of 34 oral tables of 200mg each for Rs 3,500, the cost of the 14-day treatment will be around Rs 14,000.
The dosage regimen is 3,600 mg on day one, and 1,600 mg from day two onwards for a maximum 14 days.
Emergency use means every patient must give his or her informed consent before starting treatment.
“The company has already started production of the drug. In some states that are closer to our manufacturing unit in Baddi (Himachal) the drug will be rolled out by this (Saturday) evening, and across India we should be able to supply by early next week,” said Sujesh Vasudevan, president, India formulations, Middle East and Africa, at Glenmark.
On Friday, the company had announced it received approval from India’s central drugs regulator for manufacturing and marketing FabiFlu as an oral antiviral drug to treat mild to moderate Covid-19 cases in India.
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.
“The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. 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. Of most importance, Favipiravir has shown clinical improvement of up to 88% in Covid-19 mild to moderate cases,” the company said in a presentation at a press briefing.
The drug needs to be started early for it to show maximum benefits. “Antivirals work the best when they are started early, same is the case with Favipiravir. The evidence shows it will prevent patients from progressing to severe disease, and turning critical if the drug is administered in early stages of the disease when flu-like symptoms appear in mild cases, or when lung infection sets in in moderate cases,” said Monika Tandon, vice president and head, clinical development, Glenmark Pharmaceuticals.
Randomised clinical trials in India have been conducted in 150 covid-19 patients at 11 hospitals, who were diagnosed positive through a reverse transcriptase-polymerase chain reaction (RT-PCR) test. Of them, 90 were mild cases and 60 were moderately sick patients.
“The Indian study as well as the other global studies point to the fact that the drug leads to rapid reduction in viral load, faster fever reduction, faster resolution of chest CT changes and faster clinical recovery,” said Tandon.
The medicine, however, is not recommended for people suffering from severe kidney or liver disease, pregnant and lactating women, and also those sensitive to Favipiravir.
The company’s priority is the Indian market, but it is also exploring the possibility of exporting the drug.
“Our priority remains India and later other markets. Exports will depend on regulatory requirements in those countries. There is a possibility for export in Middle Eastern countries but it’s too early to say anything conclusively right now,” said Vasudevan.
Currently, the injectible antiviral Remdesivir and immunosuppressant Tocilizumab are part of India’s treatment protocol, under restricted and off-label use, for Covid-19 patients.
Experts in the field find the study results promising, “The initial data looks promising, and we will get to see how well it works once we start using it,” said a senior doctor treating Covid-19 patients in a private hospital on condition of anonymity.
