The drug can, however, help amid rising cases of COVID-19
As Glenmark Pharmaceuticals launched antiviral drug Favipiravir for the treatment of mild to moderate COVID-19 cases, medical experts have cautioned against seeing it as a ‘magic bullet’ to treat the deadly virus but said it will be helpful as it can be orally administered and reduce viral load.
They said the drug’s real efficacy would be known in the coming months.
Glenmark Pharmaceuticals said it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet.
FabiFlu is the first oral Favipiravir-approved medication in India for the treatment of COVID-19, it said in a statement.
“This drug was already being used in Japan for influenza. They have been using it in COVID-19 patients also. Even China was using it and Russia had also given permission in May to use it. Antiviral drugs like Remdesivir and Favipiravir are not specific to COVID-19 but were being used for influenza,” said Dr Vikas Maurya, Director, Department of Pulmonology and Sleep Disorders, Fortis Hospital, Shalimar Bagh.
He said studies found that there was some benefit of Favipiravir in COVID-19 treatment and that is why it has now been launched in India as well.
Maurya said with COVID-19 cases rising, the launching of the drug comes as a relief.
“It is not a magic bullet as it is not the only thing we have to give. This is not a specific drug made for COVID-19 and has been found to be useful, but how much it will be useful we will have to see. Real efficacy will be known when administered on a large scale,” he said.
“The best thing is that it is an oral drug, while Ramdesiver is an intravenous drug. It (Favipiravir) can be even taken at home. So even if it is giving some benefit, it will be quite useful,” Maurya said.
Dr Rommel Tickoo, Associate Director, Internal Medicine, Max Healthcare, said the drug could be a “potential game-changer”.
“We don’t have much data, but whatever data we have shows that it is promising. We will have clearer information about the efficacy of the drug in the next two months. The preliminary report is promising which means that they (Glenmark) know that it works,” he said.
“It has to be given at an early stage and is a potential game-changer as it can be given in tablet form and thus is easy to administer, and is relatively inexpensive,” he said.
Tickoo said the drug could reduce the viral load when given at an early stage and also has the potential to prevent stage progression so it could reduce the hospitalisation rate which in turn could reduce the burden on the health infrastructure.
“With cases rising, at least we have something in hand,” he said.
Noted lung surgeon Dr Arvind Kumar said he does not believe that any of these antiviral drugs like Remdisiver or Favipiravir will be game-changers.
“If at all ‘game-changer’ can be used, it is for dexamethasone which has shown a significant reduction in mortality and is available cheaply,” he said.
There are so many medications available and Favipiravir will also help some patients, added Kumar, who works at Sir Ganga Ram Hospital in New Delhi.
The Favipiravir drug will be available as a 200 mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.
It is a prescription-based medication with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, it added.
The tablets are being produced by the company at its Baddi facility in Himachal Pradesh. The drug will be available both through hospitals and the retail channel, Glenmark said.
The Mumbai-based firm had received the manufacturing and marketing approval from the Drugs Controller General of India (DCGI).
“This approval comes at a time when cases in India are spiralling like never before, putting tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said in the statement.
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 option of timely therapy, he added.
The approval’s restricted use entails responsible medication usage where every patient must have signed informed consent before treatment initiation, Glenmark said.
Favipiravir can be used for coronavirus patients with comorbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms, Glenmark added.
It offers a rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement.
Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases, it said.
Considering the emergency and unmet medical need for COVID-19, the DCGI under the fast-tracked approval process granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market Favipiravir (200 mg) tablet.
Glenmark pharmaceuticals were the first company in India to initiate phase three clinical trials on Favipiravir for COVID-19 patients in India.