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Glenmark's FabiFlu approved for COVID-19 treatment in India; priced at Rs 103 a tablet

Glenmark developed active pharmaceutical ingredient and formulation for FabiFlu through in-house R&D; DCGI allowed fasttrack trials with Phase III in limited patients; approval process is also under Emergency Use Authorisation

twitter-logoPB Jayakumar | June 20, 2020 | Updated 16:35 IST
Glenmark's FabiFlu approved for COVID-19 treatment in India; priced at Rs 103 a tablet
The drug acts by getting into cells and inhibit the activity of viral replication to reduce the viral load.

KEY HIGHLIGHTS

  • Glenmark first pharma firm to get approval for an oral drug to treat COVID-19 patients in India
  • Priced at Rs 3,500 for 34 tablets, the dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days
  • Global trials show the efficacy of over 80-88%; Japan, Bangladesh and UAE already use the drug for COVID-19 treatment
  • Strides Pharma, Brinton Pharmaceuticals, Lasa Supergenerics and Optimus Pharma among firms readying its launch
  • API and formulation developed by Glenmark's in-house R&D unit

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 the 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 spiralling 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 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 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, 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 80 per cent plus success rate and a trial among 2,141 patients in Japan showed above 88 per cent success rate.

READ: Glenmark drug gets DCGI nod; claims 88% mild to moderate COVID-19 patients recovered during trials

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