COVID-19 treatment: DCGI-approved FabiFlu to cost Rs 103 per tablet

Glenmark Pharmaceuticals became the first Indian company to launch an antiviral drug named FabiFlu for the treatment of mild to moderate symptoms of COVID-19, the respiratory illness that has made over nine million people sick globally in just six months.

The medicinal salt in FabiFlu, which is available in tablet form, is currently undergoing various clinical trials with two studies showing positive outcomes in the treatment of the novel coronavirus infection, caused by the SARS-CoV-2 virus.

The Indian pharma company received approval for FabiFlu from the Drugs Controller General of India (DGCI) on Friday, 19 June.

FabiFlu is derived from favipiravir, an antiviral drug that has already been available and approved to treat influenza in countries like Japan. According to the United States National Library of Medicine, "Favipiravir is a pyrazinecarboxamide derivative with activity against RNA viruses."

The SARS-CoV-2 virus is an RNA virus—meaning that the genetic material in the virus is RNA (instead of DNA).

Favipiravir has been in use since 2014 when it was first approved to treat new or re-emerging influenza outbreaks. The drug acts by blocking the activity of RNA polymerase, an enzyme, which is necessary for the replication of the virus in the body.

Glenmark Pharmaceuticals had gone into testing with a two-pronged strategy, testing the efficacy of favipiravir as a monotherapy as well as combining the drug with umifenovir, a drug that has been used prophylactically to treat influenza types A and B in countries like China and Russia.

The Russian ministry of health has included Avifavir, which is based on the active substance in favipiravir, as a nationally recommended drug for the treatment of COVID-19.

Favipiravir study in China
Glenmark Pharma's development of FabiFlu

Doctors for COVID-19 treatment: DCGI-approved FabiFlu to cost Rs 103 per tablet

Favipiravir study in China

An earlier study on the nature of the SARS-CoV-2 virus enrolled 35 patients for treatment with a favipiravir-based drug, while another batch of patients was enrolled after having received treatment with another drug. Two patients from the favipiravir group tested negative after 18 and 21 days, respectively, while other patients in the controlled group tested negative within 27 days of receiving treatment.

The study, done by Chinese scientists, was published in the journal Engineering in March 2020. The study also found that SARS-CoV-2 has a genetic sequence that is 75-80% similar to the SARS-CoV virus which caused the deadly severe acute respiratory syndrome outbreak in 2002-03.

Another clinical trial conducted in Wuhan, where the SARS-CoV-2 virus is believed to have originated from in China, was performed through a randomised trial on patients admitted in multiple centres. Three different interventions were studied: conventional therapy, favipiravir or arbidol treatment. Arbidol, also known as umifenovir, has also been used in clinical trials for COVID-19 infection—Glenmark is also testing it in combination with favipiravir in another clinical trial.

The study in China found that arbidol may have the efficacy to treat COVID-19 as it targets the spike proteins of the SARS-CoV-2 virus, and blocks the entry of the virus into human cells. However, this earlier study suggested more investigation to study the efficacy and safety of arbidol.

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Glenmark Pharma's development of FabiFlu

According to a press release from Glenmark Pharmaceuticals on 20 June, "favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19". The company further stated that those with comorbidities, including diabetes and heart disease, showing mild to moderate symptoms of the respiratory infection, could also use this drug, which is available in tablet form.

FabiFlu will cost Rs 103 per tablet in India. Patients have been advised to take the medicine only after proper medical consultation. The drug is also currently on trial in different parts of the world for the treatment of COVID-19.

Glenmark says that FabiFlu drug reduces the viral load in a patient within four days while providing quicker improvements in symptoms and radiological (scans) findings. It goes on to add that favipiravir has shown clinical improvement of up to 88% in mild to moderate cases of the COVID-19 infection.

Favipiravir is now added to a growing list of medications and drugs being used for the treatment of various stages of the new coronavirus infection.

Earlier, remdesivir, which was originally developed for the treatment of Ebola and made by the US' Gilead Sciences, and hydroxychloroquine, a drug being used in the treatment of malaria in India, have also been in use to treat COVID-19 patients. Tocilizumab, a drug used in the treatment of rheumatoid arthritis, is being tested in Italy, and Ivermectin, an antiparasite medicine which is also used to treat other viral infections like dengue, influenza and HIV/AIDS, are also under clinical trials.