MUMBAI — Glenmark Pharmaceuticals new antiviral drug — Favipiravir with brand name FabiFlu — has been cleared for the treatment of mild to moderate COVID-19 patients in India.
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. FabiFlu will be marketed in some north Indian states soon.
The firm has become the first Indian company to commercially launch the antiviral drug.
“This approval comes at a time when COVID-19 cases in India are spiraling like never before, putting tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said.
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.
A pack of 34 tablets of FabiFlu has been priced at Rs.3,500 (Rs. 103 per tablet). The dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days of the treatment.
However, it should only be taken after a doctor's prescription. A clinical trial was conducted by Glenmark among 90 mild and 60 moderate COVID-19 patients across 11 sites in India. The drug is claimed to have an efficacy of over 80% in the treatment of mild to moderate COVID-19 patients.
Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma, Mumbai-based Lasa Supergenerics and Hyderabad-based Optimus Pharma are some of the other Indian firms that have applied for approval and are readying for its launch in India, according to sources.
A study combining two anti-viral drugs, Favipiravir (an approved drug for novel flu pandemics) with Umifenovir (an approved drug for Influenza) in COVID-19 patients is also being undertaken by Glenmark.
Favipiravir is already being used commercially in the therapeutic management of COVID-19 in Bangladesh and UAE. It is sold under the brand name Avigan by Fujifilm Toyama Chemical and is approved in Japan since 2014 in treating influenza.
It is under the approval process in Egypt and Jordan and is a part of the treatment protocol in Russia, Japan and Saudi Arabia. About 18 global clinical trials in 3,000 subjects are going on including in India, USA, Canada, Italy, China, France, UK and other countries. — Agencies
