Dive Brief:
- Fujifilm is boosting production of its influenza drug favipiravir, sold in Japan as Avigan, for use in treating patients with COVID-19, the disease caused by the new coronavirus.
- The Japanese drugmaker said it's freeing up extra capacity for manufacturing pharmaceutical intermediates needed for Avigan at its Wako Pure Chemical facility in Japan and will also rely on strategic partnerships with domestic and foreign companies.
- By July, Fujifilm expects to be able to manufacture as many as 100,000 treatment courses of Avigan a month, 2.5 times more than its production at the beginning of March. By September, the company wants to increase that figure to 300,000 treatment courses a month.
Dive Insight:
Japan is betting on Avigan even as other nations are wary of the medicine. It’s never been approved outside Japan for the flu, amid concerns about side effects including birth defects.
Avigan is thought to work by interfering with a viral enzyme that's necessary for the flu virus to replicate, and it may have a similar effect on the coronavirus, Fujifilm said in an April 15 statement.
The Japanese government plans to buy 2 million treatment courses of the medicine for its stockpile, with funds from an emergency economic package, Fujifilm said. Japanese Prime Minister Shinzo Abe has also reportedly been pushing the drug’s benefits, including in a conversation with President Trump, Politico reported.
After the conversation, Trump administration officials began to encourage regulators to allow the use of Avigan for COVID-19 patients, according to Politico. The Food and Drug Administration told Politico it wouldn't comment on the potential for an emergency use authorization for any product.
It wouldn’t be the first time that Trump has pushed an unproven medicine to treat COVID-19. During a March press conference, he referred to Gilead's experimental Ebola drug remdesivir, as well as the malaria medicine chloroquine, as potential "game-changers" for the disease.
The FDA in late March granted emergency authorization to two versions of chloroquine, allowing distribution of millions of doses of the drug from a national stockpile to states and hospitals.
Concerns about Avigan go beyond the U.S. South Korean officials decided against using the medication as they fought COVID-19 in their country, citing the potential risks of side effects and a lack of data, Politico reported.
Still, U.S. clinical trials are beginning to get underway for Avigan in COVID-19. One in Massachusetts will enroll about 50 coronavirus patients, according to the company. The government website clinicaltrials.gov also lists plans for a study of 120 patients run by Stanford University.