UPDATE: Indian Company ready to launch Oral drug to treat COVID-19
Glenmark Pharma (Glenmark Pharmaceuticals) may have become the first Indian company to market a COVID-19 control drug. It received clearance from the government‚Äôs drug regulator to market and manufacturer an oral drug that will treat mild to moderate levels of the virus in Covid-19 disease.
However, the government officials and industry watchdogs have also added that this should be treated as an experimental drug only. The anti viral drug is called Favipiravir that will be marketed by the name Fabiflu. Available in the strength of 200 milligrams, it is suppose to be taken only on the prescription of a doctor.
But since the spread of the news, people are forcing doctors to prescribe the drug. ‚ÄúIt is not for blanket use,‚ÄĚ Dr Rakesh Varma, Additional Director General of Health Services, speaking to Indian media agencies. ‚ÄúThe decision to use or not use the medicine is not based on the patient. It has to be taken by the treating physician,‚ÄĚ Varma said, adding that the medicine will be administered only once the patient signs a consent form.
In the last few weeks, two other drugs Covifor and Cipremi that are administered via injections, have also received approvals.
Post the regulatory approvals, the shares of the company surged in the market by 35percent. It is worth noting that the use of Favipiravir has already been approved by medical authorities in China, Japan, Canada and Saudi Arabia among other countries.
In India, it is confirmed, that looking at the urgency in the matter, the drug seems to have received clearance under an Accelerated Approval Process, which takes into account the disease severity, rarity, and the availability or lack of alternative treatment. However, it is also looking like that the drug would only be for “restricted emergency use” in the country, according to official spokesperson of Glenmark Pharma.
Glenmark is said to have developed the active pharmaceutical ingredient and formulation for FabiFlu through its own in-house R&D. Fast track trials were allowed by Drug Controller General of India (DCGI) to Phase III in limited patients. Prescribed dosages must be taken in consultation with a doctor. The launch will also be supported by Indian companies like Strides Pharma, Brinton Pharmaceuticals, Lasa Supergenerics and Optimus Pharma.
There have already been global trials and most show the efficacy of over 80-88% while Japan, Bangladesh and UAE have already use the drug for Covid-19 treatment. Favipiravir has been used in Japan since 2014 to cure influenza and sold under the brand name Avigan by Fujifilm Toyama Chemical. However, the same had also been used under experimental conditions only. Japanese Prime Minister Shinzo Abe, who had initially talked up the drug, maintained that there is no solid evidence yet that Favipiravir is effective against Covid-19.
The drug acts by getting into cells and inhibit the activity of viral replication to reduce the viral load. A high rate of viral replication can be controlled with early use of antiviral drugs. In later stages, viral replication slows down and the body’s violent immune response drives disease to complications and organ failure, said the company sources.
Under approval process in Egypt and Jordan, it is a part of the treatment protocol in Russia, Japan and Saudi Arabia too. Currently, there are about 18 global clinical trials being conducted on almost 3,000 subjects in India, USA, Canada, Italy, China, France, UK and other countries.
India has surging numbers of Covid-19 infected patients that has touched nearly four lakh lives, with as many as 13,000 deaths and fatality rate of 3.28%. On 20th June itself, almost 14,516 new cases were reported in India. Amidst the regulatory filing, the company spokesperson has confirmed that the drug would cost Rs. 3500 for a set of 34 tablets i.e. Rs 103 per tablet.