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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Another North Goa nightclub sealed; Kejriwal says corruption led to fire tragedy
Panaji (PTI): As part of a crackdown against tourist establishments violating laws and safety norms in the aftermath of the Arpora fire tragedy, Goa authorities on Saturday sealed a renowned club at Vagator and revoked the fire department NOC of another club.
Cafe CO2 Goa, located on a cliff overlooking the Arabian Sea at Vagator beach in North Goa, was sealed. The move came two days after Goya Club, also in Vagator, was shut down for alleged violations of rules.
Elsewhere, campaigning for local body polls, AAP leader Arvind Kejriwal said the fire incident at Birch by Romeo Lane nightclub at Arpora, which claimed 25 lives on December 6, happened because the BJP government in the state was corrupt.
An inspection of Cafe CO2 Goa by a state government-appointed team revealed that the establishment, with a seating capacity of 250, did not possess a no-objection certificate (NOC) of the Fire and Emergency Services Department. The club, which sits atop Ozrant Cliff, also did not have structural stability, the team found.
The Fire and Emergency Services on Saturday also revoked the NOC issued to Diaz Pool Club and Bar at Anjuna as the fire extinguishers installed in the establishment were found to be inadequate, said divisional fire officer Shripad Gawas.
A notice was issued to Nitin Wadhwa, the partner of the club, he said in the order.
Campaigning at Chimbel village near Panaji in support of his party's Zilla Panchayat election candidate, Aam Aadmi Party leader Kejriwal said the nightclub fire at Arpora happened because of the "corruption of the Pramod Sawant-led state government."
"Why this fire incident happened? I read in the newspapers that the nightclub had no occupancy certificate, no building licence, no excise licence, no construction licence or trade licence. The entire club was illegal but still it was going on," he said.
"How could it go on? Couldn't Pramod Sawant or anyone else see it? I was told that hafta (bribe) was being paid," the former Delhi chief minister said.
A person can not work without bribing officials in the coastal state, Kejriwal said, alleging that officers, MLAs and even ministers are accepting bribes.
