Favipiravir In India: Approved, Competition But What is Real Efficacy?

Jul 24, 2020 | Avigan, COVID-19, FabiFlu, Favipiravir, India, News, Popular Posts, SARS-CoV-2

Favipiravir Approved to Target Mild to Moderate COVID-19 Patients in India & ‘Bare Knuckle’ Competition Ensues But Does it Work

Antiviral medication Favipiravir has been approved as a treatment for COVID-19 in Russia, China and India, not to mention Bangladesh and other nations. Now yet another generic version of the drug that originates in Japan (Avigan) has been announced by Indian generic drug company Optimus Pharma. Branded as Favicovid, it will compete against Glenmark’s FabiFlu generic version of Favipiravir and others. A handful of clinical trials in the United States are testing the antiviral, including Stanford University. Moreover, the U.S. Department of Defense (DOD) spent over $200 million on clinical trials investigating Favipiravir just five years ago. Yet few in America have ever head of this drug.

Background

As reported in The Hindu, Optimus initiated work on Favipiravir quite early in the pandemic back in January, as it was reported the drug, in-vitro, was active against SARS-CoV-2. TrialSite has reported extensively on the Favipiravir story. Originally developed in Japan by Fujifilm Toyama Chemical Co. and known as Avigan, the drug was approved in Japan in 2014 for influenza. It became generic in 2019. TrialSite has reported that the drug is approved in China and Russia known as Avifavir

In June, Indian authorities approved the antiviral drug for “restricted emergency use” in mild to moderate COVID-19 cases in that country. Shortly thereafter, Glenmark Pharmaceuticals received the greenlight from the Drug Controller Genera of India (DCGI) to commence manufacturing and marketing.

Few in the United States are aware that the U.S. Department of Defense (DOD) spent a lot of capital investigating this antiviral product with a partner called MediVector. The studies ended with little fanfare $200 million later.

Competition Heats Up

Now Optimus Pharma, via a subsidiary, will market Favicovid. The Hindu reports that “in-house capability was leveraged to manufacture the API.” An integrated research and manufacturing operations was behind the finished dosage form (FDF). Optimus will serve as producer and distribute to intermediaries such as major pharma companies, government and hospitals who will then expedite production in a bid to make the drug available quickly and affordably.

Moreover, prescription-based Favicovid will be produced at the generic companies “USFDA and WHO-GMP-approved manufacturing facility in Hyderabad.” This version of the product will be marketed to hospitals and Indian retail outlets.

Price War

In countries like the United States, despite free market rhetoric, the country’s policies around drug production and pricing favors producers over consumers. Consequently, despite competition there, prices for many classes of drugs therapies tend to go up regardless of “free market” discussions, while in other places like India bare-knuckle price wars ensue. During the COVID-19 pandemic, Favipiravir is not immune to such economical forces as Glenmark Pharmaceuticals (Glenmark), makers of FabiFlu (Favipiravir) cut the price of the drug by 27% just a month after commercialization. While at the same time, India’s The Business Standard reports that the company initiated a post-marketing surveillance (PMS) initiative monitoring the safety of the drug in 1,000 Indian patients.

A brutal price war comes, potentially benefiting the Indian consumer/patient afflicted with COVID-19 as several companies are getting into the Favipiravir market including Strides, Cipla-BDR Pharma, and of course Optimus Pharma, which is also a contract manufacturer for local pharma companies.

How cheap is the drug getting? In the case of Glenmark, they slashed the price by  27% or to 75 rupees per tablet, which equals $1 per pill. In what is truly a competitive milieu, Glenmark told the press it can justify the cut as it has invested in efficiency and scale given both the API and formulations are produced right in Glenmark facilities in India. They purport to be driven by passing on the benefit to the Indian patient.

Is the Drug Working in India?

TrialSite has tracked news, reports and benefits from an extensive network of contacts in India. Based on research and ongoing discussions, the take away as this point is one big perplexing mixed signal; on the one hand, some hospitals such as Lok Nayak in Delhi have dropped the product due to a combination of price and the perception of mediocre efficacy while other reports of successful trials compete for mindshare. All the while, multiple companies jump into the competitive race which signals there is certainly interest in marketing the product in the pandemic.

Glenmark Phase 3 Trial Evidences Favipiravir Efficacy for Mild to Moderate COVID-19 Patients

For example, Glenmark announced positive outcomes from their Phase 3 clinical trial conducted across seven investigational sites across India. 

The Study

Glenmark sponsored the open-label randomized, multicenter Indian clinical trial involving 150 patients to investigate the efficacy and safety of Favipiravir treatment arm versus the standard of supportive care alone (control arm), in mild to moderate COVID-19 patients, randomized within a 48-hour window of testing RT-PCR positive for COVID-19.

Results

In the study, COVID-19 patients were administered Favipiravir and reported faster cure times and viral clearance than compared to mild to moderate COVID-19 patients on the standard of care. 

Specifically the company reported, “Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 percent faster clearance in the overall population as measured by the medium time until cessation of oral shedding of virus in the Favipiravir treatment arm compared to those in the control arm.”

Those on favipiravir achieved ‘clinical cure’ 40 percent faster than those in the standard of care. 68.9 percent of patients on Favipiravir achieved clinical cure by day 4, which the sponsor reported was statistically meaningful compared to 44.9 percent for those in the control arm.

Prominent Principal Investigator

The study was led by Dr. Zarir Udwadia, one of the principal investigators of the clinical trial. Dr. Udwadia reported, “The results of the Indian Favipiravir study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed. I have had a chance to independently view the final results and they are encouraging.”  Note the trials results have not been submitted for publication in a peer-reviewed journal yet but that is in the works in the weeks ahead.

Conclusion

Antiviral Favipiravir has been approved in several of the world’s most populated countries. The product was investigated by the U.S. DOD but little has been discussed since the last clinical trial in 2015. Meanwhile, Japan has approved the drug as an antiviral since 2014. Russia has developed its own generic version and India will have multiple versions via its cut-throat competitive generic drug producers.

Now a consumer/patient with COVID-19 can pick up a tablet for $1. Of course, a full treatment will cost more and this still adds up to too much for most of India’s lower economic strata which unfortunately is in the hundreds of millions. TrialSite has picked up reports of product dumping as well as significant randomized controlled studies showing positive efficacy.

Meanwhile in the U.S., although few Americans have ever heard of the term Favipiravir, Stanford University and a few other prominent academic medical centers are conducting clinical trials to investigate the product for COVID-19 treatment. 

Does the product work? There is certainly evidence that it helps. Remember Remdesivir was ruled to be the new standard by Dr. Anthony Fauci for COVID-19 after a trial that evidenced it cut the illness time by 3 to 4 days.  There happens to be plenty of observational data that Remdesivir has saved lives, so TrialSite supports Dr. Fauci’s position. 

However, the lack of intellectual curiosity in therapies such as Favipiravir, or Ivermectin for that matter, given the United States has become the epicenter of the COVID-19 pandemic with over 4 million cases and nearly 150,000 deaths perplexes the inquiring mind. 

Why hasn’t there been more of a prominent discussion about Favipiravir there? Why isn’t the medical community looking into this drug? Did the DOD clinical trials with MediVector reveal that it wasn’t effective? Do the economics make it such that producers aren’t interested in making it: e.g. would the pursuit of shareholder value realization be adversely impacted? TrialSite can’t be certain what the underlying story is and perhaps it is so complex and intertwined that the unraveling of this whole thing becomes too serious of an undertaking. TrialSite Network: chime in and comment.

Source: The Hindu

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