The competition has led to a steep price drop; the price of the drug has declined by as much as 66 percent.
Lakshmi*, 47, a homemaker in Hyderabad, was having intermittent cough, chest congestion and fever. Her RT-PCR test came positive for COVID-19. Her condition was diagnosed as mild-moderate, and the doctor treating her prescribed Glenmark's antiviral drug Fabiflu or Favipiravir.
Within four days, Lakshmi's symptoms vanished, and a few days later she was tested negative.
Glenmark's data from clinical trials involving 150 subjects showed that about 70 percent of the patients being treated with the drug achieved clinical cure by the fourth day of the study, compared with about 45 percent in the standard care group. Despite the company's encouraging data, many experts aren't convinced. They say that mild cases often resolve themselves without any treatment or with just standard care like paracetamol and multi-vitamin pills, and there is no need for costly treatment.
But that's not stopping doctors from prescribing Favipiravir for COVID-19 patients.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Dr. Rahul Pandit, Senior Intensive Care Specialist and Director of Critical Care Medicine & ICU at Fortis Hospital, Mulund says for mild disease Favipiravir can be recommended.
"There are two antivirals; Favipiravir and Remdesivir. The data on Remdesivir is better than Favipiravir. But there is a difference between these two drugs. Remdesivir is an injectable drug while Favipiravir is an oral medication," Pandit pointed out.
"Glenmark study was very small and the data was not very convincing to recommend it; however, when we don't have anything to use against COVID-19, Favipiravir did show that the viral clearance was definitely achieved. The mortality benefit is not significant in Favipiravir or Remdesivir, but that's not the endpoint. We only looked at viral clearance. Also, the ease of giving it orally makes it probably better acceptable than other drugs which are not antiviral agents," he added.
Pandit is also a member of the Maharashtra COVID-19 task force.
Doctors also take comfort that this is an old drug meant for the treatment of influenza.
Favipiravir, a broad-spectrum antiviral, was originally developed by Toyama Chemical Co, a subsidiary of Japanese drugmaker Fujifilm. The drug was approved in Japan in 2014. Following the COVID-19 outbreak, doctors in China and Russia have started using it to treat COVID-19 patients.
The Drug Controller General of India in June approved the use of Glenmark's Favipiravir version for restricted emergency use in mild to moderate COVID-19 cases.
But the increase in acceptance of the drug among doctors and rising COVID-19 cases are pushing pharma companies to boost Favipiravir production.
India has reported 1.96 million COVID-19 cases, and 40,699 deaths. In India, the cases are rising at a fast pace - more than 50,000 a day - with most cases coming from smaller towns and villages.
Pharma companies that are quick to spot the trend have jumped into the race to launch Favipiravir. At least a dozen drugmakers including the big ones such as Sun Pharma, Cipla, Lupin and Alkem have launched generic versions of Favipiravir so far, and many more are in line to launch the drug.
Steep price drop
The competition has led to a steep price drop. The price of the drug has declined by as much as 66 percent.
Glenmark launched Favipiravir in late June at Rs 103 per tablet, but has slashed the price to Rs 75 per tablet last month. India's largest drugmaker Sun Pharma launched the cheapest Favipiravir at Rs 35 per tablet. A full course of Favipiravir for mild-to-moderate COVID-19 involves up to 122 tablets over two weeks.
"Favipiravir is fast replacing paracetamol as the standard of care for mild-to-moderate COVID-19, and we are seeing huge demand," Prashanth Reddy, Director of Optimus, told Moneycontrol.
Reddy says the feedback he is getting from doctors is that the drug is stopping the infection spreading to lungs, thereby reducing mortality.
Optimus has approvals for both the active pharmaceutical ingredient and formulations. The company said it will be producing about 10 million tablets in August and next month, it is planning to increase supplies by 50 percent.
The drug is here to stay for a while, said another senior executive of a large India pharmaceutical company that also has launched Favipiravir.
"We are seeing over 50,000 new cases daily; while the majority are asymptomatic cases, we assume at least 10,000 - 15,000 cases would be mild-to-moderate, eligible for Favipiravir," the executive said.
The executive added that it makes sense for pharma companies to have Favipiravir in the portfolio, when they reach out to physicians.*Name changed to protect privacy.