On Saturday, Mumbai-based pharmaceutical company, Glenmark, was the first to receive approval for the manufacture and marketing of antiviral drug favipiravir in India. It is shown, by research, to be one of the medicines that could act as a potential treatment for Covid-19.
It is reported that the Drugs Controller General of India (DCGI) has approved the medicine for “restricted emergency use” only for the treatment of COVID on Friday.
On Saturday, Glenmark, in an official press statement and a media conference, announced that the drug is ‘advised for mild to moderate’ cases. It is through Glenmark’s in-house research and development, that the active ingredient and the formula for FabiFlu were developed.
The DCGI, under the Emergency Use Authorization (EUA), has allowed the drug to be used as fast track trials with Phase III in some patients. The company has said that the drug will be launched before the month-end. At the cost of INR 103 per tablet, it’ll probably be available on prescription, across India.
Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals, stated, “The approval comes at a time when cases in India are spiraling like never before and putting tremendous pressure on our healthcare system. FabiFlu will reduce this pressure. Glenmark will work with the government and medical community to make it quickly accessible to patients across the country.”
At the moment, favipiravir is under trial status in almost 18 clinical trials across various countries including India, China, USA, Canada, amongst others. More than 3,000 subjects are involved globally.
Favipiravir, soon to be marketed as FabiFlu, works by getting into the cells and stopping the virus from replicating, ultimately reducing damage. Viral replication can be stopped by preventive anti-viral drugs like these.
A Chinese health official was quoted saying that “the use of favipiravir showed definite improvements in lung condition in 91 percent of the patients treated with it, compared to 62 percent of those treated without the drug”, reported the Guardian.
It was initially developed in Japan and approved as an anti-viral medication for influenza patients. A lot of drugs are also under trial, with each hoping to be successful in curing this world of the pandemic. The outcomes in Wuhan and Shenzhen have also yielded positive responses after the use of this drug.
Approved for compassionate usage in Japan, Favipiravir is also being tested in other places and is showing potentially positive results. According to reports, pharmaceutical companies across India, like Brinton Pharmaceuticals, Strides Pharma, Lasa Supergenerics, and Optimus Pharma, among others, have applied for seeking approval and launching this in the country.
Inputs from Yukta Baid