5/15/2020 Ministry speeds approval process for Avigan to treat COVID-19 : The Asahi Shimbun

Ministry speeds approval process for Avigan to treat

COVID-19
THE ASAHI SHIMBUN
May 13, 2020 at 16:43 JST

The health ministry on May 12 decided to allow

pharmaceutical companies to bypass some
clinical trial procedures for the fast-track
approval of candidate drugs to treat COVID-19,
including the anti-flu medicine Avigan.

The companies will not be required to submit

Anti-flu drug Avigan, produced by an affiliate of
Fujifilm Holdings Corp., is drawing attention as a
potential treatment for COVID-19. (Provided by
Fujifilm Holdings Corp.)
the novel coronavirus pandemic.
the results of clinical trials in advance if the
safety and efficacy of the drugs are confirmed in
public studies that have received grants from
the ministry or the Japan Agency for Medical
Research and Development.
The exception to the pharmaceutical
regulations was made as the world races to
produce a vaccine or effective treatment to halt

However, some health experts say the Japanese government, again, is rushing matters and could
be putting people’s health at risk.

Clinical trials are conducted to confirm the safety and efficacy of pharmaceutical products, and the
results are normally submitted to regulatory authorities when applying for approval.

The exception will be applied for drug applications that satisfy one of two requirements: public
studies conducted on the drug meet global standards, or companies that developed the drug plan
to conduct clinical trials and submit the results to the health ministry.

As for the latter requirement, the ministry will ask the companies to submit the results of the
clinical trials after the drug is approved.

The ministry explained that the exception is aimed at putting effective COVID-19 medicine into
practical use as quickly as possible.

Avigan was produced by Fujifilm Toyama Chemical Co. and approved for use as a treatment for
new strains of influenza.

Prime Minister Shinzo Abe said the government plans to have Avigan approved as a treatment for
COVID-19 by the end of May.

Although the results of Fujifilm Toyama Chemical’s clinical trials on Avigan for COVID-19 are
expected to take some time, the drug has already been administered to many patients in
observational studies carried out by doctors.

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5/15/2020 Ministry speeds approval process for Avigan to treat COVID-19 : The Asahi Shimbun

Under the ministry’s exemption, the company can apply for approval of the drug based on the
results of the observational studies.

However, some studies have shown that Avigan used during pregnancy can have severe side effects
on the fetus.

“The exception was made hastily,” said Jugo Hanai, who contracted HIV from tainted blood
products and serves as a member of the Pharmaceutical Affairs and Food Sanitation Council, an
advisory panel to the health minister.

“I understand there’s no other choice but using drugs that might be effective even a little bit since
available treatment is limited, but the drugs should not be approved (in such a manner),” Hanai
said.

“The approval would also allow such drugs to be used at medical institutions with a low level of
pharmaceutical management and could result in causing side effects on patients.”

The Japanese government last week approved the use of the drug remdesivir, which was originally
developed to treat Ebola virus infections, for treatment of COVID-19 patients.

Health experts in Japan have questioned the effectiveness of remdesivir against COVID-19 and
raised concerns about possible side effects from its use.

(This article was written by Shuichi Doi and Hajime Mikami.)

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