Glenmark Favipiravir can be used in mild Covid cases, says doctor; Check out Consent Form
Meanwhile, Glenmark has released a consent form. A copy of which is with Medical Dialogues. Entailing responsible medication use, the form should be mandatorily signed by every patient before treatment initiation. The form seeks necessary details including the Physician’s signature, Name, and Signature of the Person providing consent (Patient, Legally authorized representative, parent, or guardian).
They said the drug's real efficacy would be known in the coming months.
Meanwhile, the company has released a consent form. A copy of which is with Medical Dialogues. Entailing responsible medication use, the form should be mandatorily signed by every patient before treatment initiation.
The form seeks necessary details including the Physician's signature, Name, and Signature of the Person providing consent (Patient, Legally authorized representative, parent, or guardian).
The 'Informed consent' form reads, "I understand that Fabiflu approval has been granted as part of the accelerated approval process considering the emergency situation and unmet medical need in light of Covid-19 outbreak in India for restricted emergency use by Government (office of DCGI, Ministry of Health and Family Welfare, Govt. of India New Delhi) in the current pandemic situation of Covid-19."
"I have also been explained about the possible benefits as well as risks (including the side effects) from the usage of this drug by my treating physician, after which I have made an informed choice to take this Favipiravir tablet (Fabiflu) willingly and under no undue pressure," the form adds.
It further states, "I also confirm that I have had a chance to read or be explained the contents of the Product Information leaflet / sheet that carries all the information on the usage, indication, possible adverse effects and contraindications for Fabiflu."
Clarifying furthermore, the form reads, "I understand that if I have questions, concerns, or complaints, or think the treatment has in any way hurt me, I am at liberty to withdraw the consent for my treatment with Fabiflu without giving any reason whatsoever and /or can talk to my doctor. I agree to the fact that the data being generated out of my usage of this Fabiflu may be used by Glenmark for Scientific purpose/s only."
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 told PTI.
"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 told PTI.
"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 hospitalization rate which in turn could reduce the burden on the health infrastructure.
"With cases rising, at least we have something in hand," he told PTI.
Noted city-based 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 here.
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 on Friday 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 a 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 co-morbid 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 percent 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 was the first company in India to initiate phase three clinical trials on Favipiravir for COVID-19 patients in India.