Doctors are prescribing ever more numbers of favipiravir-based drugs for patients with mild COVID-19 as it actually becomes India’s top selling drug in September with locally produced products that generated just under $20 million (US). Domestic brands are selling fast since their launch in June and, of course, as COVID-19 infections spread. The data was derived from IMS IQVIA and the All Indian Origin Chemists & Distributors (AIOCD).
Favipiravir Approved in World’s Most Populous Nations
With the brand name Avigan (FUJIFILM), TrialSite has chronicled this drug extensively. The antiviral was approved by Japan’s drug regulatory authority in 2014 for influenza. The U.S. Department of Defense studied the drug extensively in Phase 3 clinical trials costing over $200 million as recently as 2016. Favipiravir-based products have been approved for the indication of COVID-19 in Russia, China, Bangladesh and India as well as elsewhere. FUJIFILM, the original maker, is on the verge of approval in Japan for mild COVID-19 indication. A few clinical trials are occurring in the United States investigating its safety and efficacy in treating mild to moderate COVID-19 patients. India’s DCGI approved favipiravir for pandemic emergency use only. The Indian Council of Medical Research (ICMR) has yet to include favipiravir on its national COVID-19 treatment recommendation.
Next to the United States, India is now the epicenter of the COVID-19 pandemic with 6.23 million cases and just under 100,000 reported deaths. India’s population appears to be more resilient to the pathogen, as about 70% of the reported cases have only mild symptoms.
Favipiravir Boom in India
TrialSite reported on a number of different generic pharma company initiatives to develop and private label favipiravir products. The Economic Times in India now reports 10 favipiravir-based brands in India, led in sales by Glenmark’s FabiFlu followed by Ciplan and Lupin.
Intense competition of course has led price declines in bids for position and market share. Prices have been cut to Rs 30 per tablet or about 41 cents per tablet.
Recent Trial Results in Japan
TrialSite reported that FUJIFILM reports positive clinical trial results. The drug reduced period of illness duration by three days. Consequently, the company reports its planning to register with the Japanese authorities for the new indication (e.g. COVID-19).
Some Still Skeptical
TrialSite wondered about the true efficacy of favipiravir. https://trialsitenews.wpengine.com/can-favipiravir-compete-against-remdesivir-in-north-america-targeting-covid-19/ Skeptics in India abound and apparently some experts from the Indian national task force aren’t buying into the antiviral till a ICMR favipiravir study concludes. The ICRM won’t include favipiravir in its national COVID-19 guidelines until the recent Japanese FUJIFILM study results are published in a peer review journal.
How about the USA?
Presently, no products have been officially approved for COVID-19. A total of three products have been accepted for use in certain circumstances. Absolutely no products have been authorized or accepted for early to moderate stage condition—the great majority of COVID cases. The population of nearly 340 million must literally sit and wait for major drug manufacturers. Although physicians are supposed to be able to use FDA-approved drugs off label, with the novel coronavirus, even the clinic is directed to hold off and wait.
The one big and noteworthy “approval” is for remdesivir, and certainly questionable. In the unprecedented move, the sponsors (Gilead and National Institutes of Allergy and Infectious Diseases) changed the endpoints so that they could report on positive results. See TrialSite’s “No Knockout Drug but Knocking it out of the Ballpark.”
Remdesivir can only be administered intravenously, hence patients must be in a healthcare provider facility. As TrialSite chronicled, the cost per-treatment ranges from $2,340 per treatment for five day course (gov payer) to $3,120 for private payer. Given the tens of millions don’t have insurance, given pandemic layoffs, this means that this drug is out of reach for millions of Americans. Ironically, Gilead, a great American company, really tried to price it reasonably—ICER supports their pricing model.
Another economic therapy placed on the NIH’s list of treatments includes dexamethasone, but this is for severe cases (See RECOVERY trial).
The FDA, in what many criticized as a move influenced by politics, gave the greenlight for convalescent plasma as well under emergency use authorization. Again, this requires hospitalization and doesn’t apply to the great majority of cases.