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Avigan fails to prove COVID efficacy in U.S. trials, in blow to Fujifilm

Company will continue efforts in Japan, but path to American market looks closed

Fujifilm and its partner had hoped to request emergency use authorization of Avigan as a COVID-19 treatment as early as this year. 

TOKYO -- Fujifilm Holdings' flu-fighting drug Avigan failed to prove sustained clinical recovery from COVID-19 in a test conducted by a Canadian partner in the U.S., Mexico and Brazil, significantly hampering its chances of implication in the American market.

Appili Therapeutics, the Halifax-based partner, said the Phase 3 clinical trial evaluating oral antiviral Avigan for the treatment of mild to moderate COVID-19 "did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery." Additional analyses of the trial data are ongoing, the company said in a news release Friday.

The clinical trial enrolled 1,231 patients with mild-to-moderate symptoms from 38 study sites across the three countries.

Appili had hoped to request emergency use authorization with the U.S. Food and Drug Administration as early as this year if the trials had been successful. But the failed trials all but shut the door to use in the U.S.

Developed by Fujifilm group unit Fujifilm Toyama Chemical, Avigan has been approved in Japan as a treatment for influenza. The drug is known to suppress the growth of viruses that have entered cells.

Unlike most other treatments that researchers are evaluating to treat COVID-19, Avigan "has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug," Appili said.

While many other treatment options require temperature-controlled storage, the oral tablet is shelf-stable. Its established commercial manufacturing process was also seen as an advantage.

Fujifilm began clinical trials in Japan in March 2020 as a treatment for COVID-19. In October that year, it requested authorization from Japan's Health Ministry to produce and sell the product but could not win the green light. The ministry's expert board postponed the decision in December, opting to examine more evidence to determine its efficacy.

In April this year, Fujifilm restarted clinical trials in Japan under new conditions. The U.S. clinical trial was running simultaneously, and the company had hoped to use the American data to help its case in Japan.

Fujifilm said in a statement Saturday that it will wait for the additional analyses of the trial data. "We will refrain from commenting at this time," it said.

As for clinical trials in Japan, Fujifilm said, "We will continue to make efforts to conclude [the tests] at an early date." But with infection rates coming down in Japan, the company will struggle to conduct the number of trials needed.

Meanwhile, rival companies are moving closer to bringing their drugs to the market.

Merck & Co's drug molnupiravir, for use in people with mild to moderate COVID-19, won approval from Britain's Medicines and Healthcare Products Regulatory Agency on Nov. 4. It has also requested emergency use authorization in the U.S. The U.S. government has signed a contract to receive 3.1 million doses, while Japan also plans to purchase 1.6 million doses for $1.2 billion.

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