New Delhi: Mumbai-based Glenmark Saturday became the first pharmaceutical company in India to get approval for the manufacture and marketing of antiviral drug favipiravir, one of the medicines that is being explored as a potential treatment for Covid-19.
The Drugs Controller General of India had reportedly approved the medicine for “restricted emergency use” as Covid-19 treatment Friday.
Glenmark said in a press statement as well as a media conference Saturday that the drug is advised for mild to moderate Covid-19 cases.
According to the company, the drug will be launched commercially next week and is likely to be available across chemist outlets, on prescription, by the end of the month. It will be priced at Rs 103 per tablet.
The antiviral medication was developed in Japan and subsequently approved for use among influenza patients. Favipiravir is among the drugs under trial for Covid-19 treatment along with Ebola drug remdesivir, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of the latter two drugs with Interferon beta.
Currently, the drug is the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries.
Early trials on the drug in China, involving 340 patients, produced encouraging outcomes in Wuhan and Shenzhen.
An 18 March report in The Guardian quoted a Chinese health official as saying that “the use of favipiravir showed definite improvements in lung condition in 91 per cent of the patients treated with it, compared to 62 per cent of those treated without the drug”.
In another observational study involving over 2,000 patients with mild to moderate symptoms in Japan, those given favipiravir reportedly showed clinical improvement of up to 74 per cent by the seventh day and up to 88 per cent by the 14th day.
Developed in 1990s
Favipravir was originally developed in the late 1990s by a company that was later purchased by Japanese Fujifilm as part of its transition from the photo business to healthcare.
After being tested against a range of viruses, the drug was approved in Japan in 2014 for emergency use against flu epidemics or to treat new strains of influenza.
Branded as Avigan in Japan, it will now be sold in India as “FabiFlu”.
It is the first medication to be approved and commercially available for the treatment of Covid-19. Since it can be taken orally, it makes the medicine more accessible and easily administrable than, for example, Gilead’s remdesivir, an injectable that is also being studied in the context of the coronavirus pandemic.
Glenmark said Saturday that the drug will be sold in a strip of 34 tablets with a dose strength of 200 mg for a maximum course of 14 days. The drug is priced at Rs 3,500, approximately Rs 103 per tablet.
However, the firm added, doctors will need a patient’s consent before prescribing the drug.
According to Glenmark, the drug can be used in Covid-19 patients with comorbid conditions such as diabetes and heart disease, who have mild to moderate symptoms of the disease.
“It offers rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement. Of most importance, favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate Covid-19 cases,” the company said in the press statement.
Glenmark said the drug is not to be administered to patients with severe kidney and liver impairment, or pregnant & lactating women.
The drug should be used with caution in patients with history of abnormalities in metabolism of uric acid or having Gout, it added.
How does the drug work?
The medicine works by “short-circuiting” the reproduction mechanism of certain RNA viruses such as influenza, a report by news agency Reuters said.
According to Glenmark, favipiravir works by entering the human cells, where it is converted into favipiravir “ribofuranosyl-5′-triphosphate”, also known as favipiravir-RTP by the host cells. A host cell is a living cell in which a virus multiplies.
Favipiravir-RTP hinders the activity of “RNA-dependent RNA polymerase (RdRp)” of the novel coronavirus, SARS CoV2. This leads to the blocking of viral replication and thus reduces the viral load and severity of the disease.
Glenmark has proposed the use of a drug in combination with umifenovir — an approved drug for influenza. “Both drugs acting on different mechanisms, the combined use of favipiravir and umifenovir offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of SARS-CoV-2 virus,” the company said in its presentation Saturday.
Favipiravir has so far been approved for experimental use among Covid-19 patients by the regulators of Italy and China. It has also been commercially launched by companies in Bangladesh.
In Japan, it is being put to compassionate use, that is, when an unapproved drug is used on serious patients in the absence of other treatments.
According to Glenmark, the Covid-19 therapeutic management guidelines include favipiravir in Russia, Japan and Saudi Arabia whereas a 760-patient trial of the drug has also been initiated in Canada at long-term care centres.
The drug’s evaluation is also underway in other West Asian countries such as Iraq and Bahrain, based on Saudi Arabia’s Covid-19 treatment guidelines, Glenmark claimed.
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