Glenmark's FabiFlu approved for COVID-19 treatment in India; priced at Rs 103 a tablet
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New Delhi: Drug major Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug - Favipiravir with brand name FabiFlu - for the treatment of mild to moderate COVID-19 patients. The company received marketing and manufacturing approval from the Indian drug regulator, Drug Controller General of India (DCGI), and launched the product in the Indian market today.
Priced at Rs 3,500 for a pack of 34 tablets (Rs 103 per tablet), the dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days of the treatment. Glenmark did a clinical trial among 90 mild and 60 moderate COVID-19 patients across 11 sites in India. The drug is claimed to have an efficacy of over 80% in the treatment of COVID-19 mild to moderate patients.
Sources said Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma, Mumbai-based Lasa Supergenerics, Hyderabad-based Optimus Pharma are some of the other Indian firms that have applied for approval and are readying its launch in India.
Glenmark had developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through in-house R&D. The DCGI allowed fast track trials with Phase III in limited patients. The approval process is also under Emergency Use Authorisation (EUA).
India has nearly 4 lakh, COVID-19 patients, now, with nearly 13,000 deaths and fatality rate of 3.28%. On 20th June, 14,516 new cases were reported in India.
"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," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.
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 the 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.
Glenmark is also undertaking a study combining two anti-viral drugs, Favipiravir (an approved drug for novel flu pandemics) with Umifenovir (an approved drug for Influenza) in COVID-19 patients.
Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical and approved in Japan since 2014 in treating influenza, is already being used commercially in the therapeutic management of COVID-19 in Bangladesh and UAE.
It is under the approval process in Egypt and Jordan and is a part of the treatment protocol in Russia, Japan, and Saudi Arabia. About 18 global clinical trials in 3,000 subjects are going on including in India, the USA, Canada, Italy, China, France, UK, and other countries.
The drug has been approved for compassionate use on 2,050 COVID-19 patients in Japan. It's also approved for novel or re-emerging pandemic influenza virus infection in the country. A 760 patient trial of Favipiravir is also undergoing in Canada. A couple of studies in China had also shown promising results. A Russian study among 390 patients had shown an 80 percent-plus success rate and a trial among 2,141 patients in Japan showed an above 88 percent success rate.
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Conspiracy afoot to 'tarnish' image of Dharmasthala: Deputy CM DK Shivakumar
Bengaluru, Aug 14 (PTI): Karnataka Deputy Chief Minister D K Shivakumar on Thursday said there was a “conspiracy” to tarnish the image of Dharmasthala.
His comments come amid an ongoing investigation by a Special Investigation Team (SIT) into serious allegations of mass burials in the revered temple town in Dakshina Kannada district.
“A conspiracy is being hatched to destroy hundreds of years of legacy. It is not correct to tarnish someone just like that. It has all happened due to one complainant,” he said.
Noting that some Congress MLAs have called for action against those involved in the slander campaign at the legislature party meeting, he said, “ I have told them that action must be taken against those who are indulging in a slander campaign. The CM has also said that action must be taken against such people.”
“I have information on this case. Religious feelings should not be hurt in any manner. Culprits must be punished,” he told reporters, according to a release from his office.
Responding to a question, Shivakumar said the Congress party will not allow the image of any religious place to be tarnished.
“We see everyone equally when it comes to religion,” he added.
The SIT, formed by the state government, is probing claims of mass murder, rape, and mass burials in Dharmasthala over the past two decades.
The complainant, a former sanitation worker whose identity has not been revealed, alleged that between 1995 and 2014 he was forced to handle bodies—including women and minors—and that some showed signs of sexual assault. He has given a statement before a magistrate.
As part of the probe, the SIT has been conducting exhumations at multiple locations identified by the complainant-witness in the forested areas along the banks of the Netravathi River in Dharmasthala, where some skeletal remains have been found at two sites so far.
