YD NEWS | Glenmark launches COVID drug FabiFlu
Mumbai: Drug firm Glenmark Pharmaceuticals on Saturday said it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate Covid-19 symptoms.
“Fabiflu is the first oral favipiravir-approved medication in India for the treatment of COVID-19: said Glenmark”
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of Covid-19, it said in a statement.
“Fabiflu can be given only with Doctor prescription”
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 drug will be available as a 200 mg tablet, at a price of about Rs 103 per tablet- said Glenmark Pharmaceuticals”
The drug will be available as a 200 mg tablet, at a price of about Rs 103 per tablet, and at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.
“The tablets are being produced by the company at its Baddi facility in Himachal Pradesh”
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.
“Firm had received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday”
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 spiraling like never before, putting tremendous pressure on our the healthcare system,” Glenmark Pharmaceuticals chairman and managing director 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 and timely therapy option, he added.
“The approval’s restricted use entails responsible medication usage where every patient must have signed informed consent before treatment initiation”
The approval’s restricted use entails responsible medication usage where every patient must have signed informed consent before treatment initiation, it added.
The company has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its in-house research and development team, Glenmark said.
“We chose to initiate work on Favipiravir, as it has proven in-vitro activity against SARS CoV2 virus, which is the virus responsible for Covid-19.
“Second is it has a wide therapeutic safety margin for Covid-19 at the dose that we administer,” Glenmark Pharmaceuticals president India Formulations, Middle East and Africa Sujesh Vasudevan said at an online press conference.
The company said that Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19.
“The antiviral offers broad-spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years,” it said.
Moreover, it is an oral product and that is a huge benefit especially when the hospital infrastructure is under strain, he added.
Manufacturing and marketing approval has been granted as part of an accelerated approval process, considering the emergency situation of the Covid-19 outbreak in India, Glenmark said.
“Fabiflu can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate Covid-19 symptoms- said Glenmark”
Favipiravir(Fabiflu) can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate Covid-19 symptoms, Glenmark said. 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 in a statement.
“Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country,” he added.
Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
Last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalised adult Covid-19 patients in India.
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