The government has decided to postpone approving Fujifilm Holdings Corp.'s Avigan drug for the treatment of COVID-19 until June or later, health minister Katsunobu Kato said Tuesday.
Prime Minister Shinzo Abe had said earlier this month he hoped the drug, known generically as favipiravir, would be approved some time in May if its efficacy and safety could be confirmed.
But Kato told a news conference Tuesday that clinical tests on the drug would continue into next month or beyond, while noting that there was no change in the government's policy of approving the drug swiftly once its effectiveness is confirmed.
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.
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 this month, said it was too early to judge it scientifically, prompting the continuance of the clinical trials, according to Kato.
The drug cannot be administered to expectant mothers or women who are likely to become pregnant as it may cause birth defects.
Aside from the tests carried out by Fujita Health University, Fujifilm is also conducting its own clinical tests of Avigan that are set to continue through the end of June.
It said Friday it was still discussing the matter with regulatory authorities and could not say when it would be able to apply for approval of the drug.
Interest in Avigan soared in March after a Chinese official said it appeared to help patients recover from COVID-19, the potentially fatal respiratory illness caused by the novel coronavirus. The medication is now the subject of at least 16 clinical trials around the world.
Japan's government has called on Fujifilm to triple national stockpiles of the drug, which was approved in 2014 as an emergency flu treatment, and has pledged to donate it to countries upon request.
Dozens of clinical trials for potential COVID-19 treatments and vaccines are ongoing across the globe. One candidate is a DNA vaccine being developed by biopharmaceutical firm AnGes Inc. and Osaka University.
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