FAVIPIRAVIR , sold under the brand name AVIGAN OR ABIGAN , is an antiviral medication used to treat influenza in Japan. It is also studied to treat number of other infections.
It is being developed and manufactured by TOYAMA MEDICAL(fujifilm group) and was approved for medical use in Japan 2014. Fujifilm licensed API for it ZHEJIANG HISUN PHARMACEUTICAL Co. of China. It become a generic drug in 2019.
Favipiravir, an antiviral medication developed in Japan, is currently the subject of 18 trials around the world as a potential treatment for Covid-19 and results from two studies have shown a positive outcome.
Favipiravir has demonstrated good results against influenza viruses and is being tested in other countries as a potential treatment against the novel coronavirus.
Mumbai-based Glenmark Pharmaceuticals has received approvals from Drug Controller General of India to manufacture and market Favipiravir, an anti-viral drug, to treat Covid-19 patients. The drug is likely to be available in the market in the next few days.
The Drugs Controller General of India had reportedly approved the medicine for “restricted emergency use” as Covid-19 treatment Friday.
In India, a randomised multi-centre study was done on Indian patients to test the drug’s efficacy and safety with standard of care vs standard of care alone in mild to moderate Covid-19, the company said. The study enrolled 150 patients. The study’s details are yet to be published in a peer-reviewed paper.
In its press release, the company cited
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 tablets.
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.
Based on Phase-3 data, the company obtained approval for manufacture and marketing of antiviral drug Favipiravir, which has been branded as FabiFlu, an oral medication.
The approval is for emergency restricted use only for treatment of mild to moderate Covid-19 patients. The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.
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.
According to a press release issued by Glenmark on Saturday, June 20, the company successfully developed the active pharmaceutical ingredient and formulation for FabiFlu through its own in-house R&D team.
The Council of Scientific and Industrial Research (CSIR) had done end-to-end synthesis of Favipiravir in April. Earlier this week, CSIR got approvals from DGCI to conduct multi-centre Phase-II trials of the drug.
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