In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals announced the launch of antiviral drug Favipiravir (brand name FabiFlu) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu the first oral Favipiravir-approved medication in India for the treatment of COVID-19. The Mumbai-based drug firm had on Friday received manufacturing and marketing approval from the Drugs Controller General of India (DCGI).
- Glenmark first pharma firm to get approval for an oral drug to treat COVID-19 patients in India
- Priced at Rs 3,500 for 34 tablets, the dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days
- Global trials show the efficacy of over 80-88%; Japan, Bangladesh and UAE already use the drug for COVID-19 treatment
- Strides Pharma, Brinton Pharmaceuticals, Lasa Supergenerics and Optimus Pharma among firms readying its launch
- API and formulation developed by Glenmark’s in-house R&D unit
FabiFlu is the first oral Favipiravir-approved medication for the treatment of Covid-19, the company said in a statement. “This approval comes at a time when cases in India are spiraling like never before, putting a tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said.
The company hopes that the availability of an effective treatment such as FabiFlu will considerably help assuage this pressure and offer patients in India a much needed and timely therapy option, he added. FabiFlu has demonstrated an encouraging response in mild to moderate Covid-19 patients during clinical trials, Saldanha said. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications, he noted.
“Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country,” Saldanha said. The drug will be available as a prescription-based medication for Rs 103/tablet, with recommended dose being 1,800 mg twice on day one, followed by 800 mg twice daily up to day 14. Favipiravir can be used for coronavirus patients with co-morbid 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, the drug maker added.
Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate Covid-19 cases, it said. The drug firm had successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its in-house R&D team. It had then filed the product for clinical trial with country’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate Covid-19 patients.
Glenmark is also undertaking 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.
Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical and approved in Japan since 2014 in treating influenza, is already being used commercially in the therapeutic management of COVID-19 in Bangladesh and UAE.
It is under 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.
The drug has been approved for compassionate use on 2,050 COVID-19 patients in Japan. It’s also approved for novel or re-emerging pandemic influenza virus infection in the country. A 760 patient trial of Favipiravir is also undergoing in Canada. A couple of studies in China had also shown promising results. A Russian study among 390 patients had shown 80 per cent plus success rate and a trial among 2,141 patients in Japan showed above 88 per cent success rate.