Japan pushes back plan to approve Avigan drug as COVID-19 treatment

​Japan has pushed back its plan of approving the anti-flu drug Avigan in May as a treatment for COVID-19 patients as clinical trials so far have not yet clearly shown the drug's effectiveness, health minister Katsunobu Kato said Tuesday.

Xinhua May 27, 2020

Japan has pushed back its plan of approving the anti-flu drug Avigan in May as a treatment for COVID-19 patients as clinical trials so far have not yet clearly shown the drug's effectiveness, health minister Katsunobu Kato said Tuesday.

"We will continue the clinical study and clinical tests of the drug in June and onwards. There is no change in our policy to approve the drug swiftly if its efficacy against the coronavirus is confirmed," Kato told a press briefing on the matter.

Avigan, developed by a subsidiary of Fujifilm Holdings, is believed to be of benefit to those diagnosed with milder cases of COVID-19, or those newly infected with the virus, as a treatment for the symptoms.

As a result, the government here set about swiftly trying to get the drug approved this month, with Japan saying it was planning to triple its stockpile of Avigan, to treat 2 million people.

Japan had also committed to making the drug available for free to more than 40 other countries for clinical trials, Foreign Minister Toshimitsu Motegi had said.

Motegi also said that around 80 additional countries had shown interest in the drug.

But interim results of clinical tests of the drug, conducted by a team led by Fujita Health University, and assessed by a third-party panel, concluded in a report that it was too early to judge the results of the trials scientifically.

"A third-party panel that assessed the results of the interim report, released in the middle of this month, said that it was too early to judge it scientifically, prompting the continuance of the clinical trials," Kato said.

As such, the trials need to be carried out for a longer period of time and along with Fujita Health University, Fujifilm is also carrying out its own clinical tests of Avigan, set to continue through June.

Kato said that 3,000 COVID-19 patients in Japan have so far been prescribed Avigan as a part of an "observational study."

If the drug is approved, Avigan would be Japan's second COVID-19 treatment authorized after the antiviral drug remdesivir, developed by U.S. firm Gilead Sciences Inc., was given approval earlier this month.

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