Japan extends timeline for approving Fujifilm's Avigan [Favi
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Fujifilm Holdings Corp’s research on Avigan as a potential treatment for COVID-19 may drag on until July, a further setback for the Japanese firm’s effort to prove the drug’s effectiveness against the virus.

“There is a possibility that clinical trials will continue in July,” a Fujifilm spokesman said, responding to a report that any approval will be delayed until July or later, due to a lack of patients for trials.

After the government of Prime Minister Shinzo Abe gave up on getting approval for the drug by the end of May, the aim was to complete clinical trials this month [June].

Some experts had raised concerns that the government was rushing to approve it and undermining strict medical procedures in place to authorize the use of drugs.

Japan's Health Minister Katsunobu Kato said the government had initially aimed to approve the drug if the interim results of clinical tests, conducted by a team led by Fujita Health University, showed extremely high effectiveness in treating COVID-19.

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

Further added, the drug cannot be administered to expectant mothers or women who are likely to become pregnant as it may cause birth defects.

Sources:
1. https://in.reuters.com/article/health-coronavirus-avigan/fujifilm-says-covid-19-drug-research-may-drag-on-into-july-idINKBN23E05M
2. https://www.japantimes.co.jp/news/2020/05/26/national/science-health/fujifilm-avigan-coronavirus/#.XvBqwGgzbIU
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