Japan's Avigan Faces Difficult Approval Review as COVID-19 Treatment... "Efficacy Assessment Challenging"

"Possibility of Doctor's Prejudice Involving No Placebo Effect"

[Image source=Yonhap News]

[Asia Economy Reporter Jeong Hyunjin] According to reports from NHK and Kyodo News on the 17th, the review process for Avigan, a pharmaceutical product developed by a Japanese company and submitted for approval as a treatment for the novel coronavirus infection (COVID-19) in Japan, is expected to face difficulties.

According to the reports, the review committee of Japan's Ministry of Health, Labour and Welfare has scheduled a review on the 21st of this month for Avigan, originally an antiviral drug for novel influenza developed by Fujifilm Toyama Chemical, which has applied for approval as a COVID-19 treatment. The committee is currently verifying the submitted trial data. The Japanese government has been accelerating efforts to facilitate the practical use of Avigan, developed by a domestic company, by preparing special measures regarding the approval application.

NHK, citing sources, reported that "it is currently difficult to evaluate the effectiveness based solely on clinical trial data." Kyodo News also cited some government officials, summarizing a report stating that "it is difficult to determine efficacy based on the developer company's clinical trials" regarding Avigan.

The Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative institution responsible for drug approval reviews in Japan, reportedly pointed out issues with the clinical trial methods and procedures for Avigan. The clinical trials were conducted using a single-blind test method, where dosing information is disclosed to the physician but not the patient, which is considered less reliable than results obtained through a double-blind test method, where neither the patient nor the physician is informed of the dosing information.

The PMDA stated in its report that because physicians may have a preconceived notion that "placebos have no effect," they might not appropriately assess symptoms. Additionally, the criteria for evaluating symptom relief, such as body temperature and oxygen saturation levels, were unclear, raising doubts about whether physicians fully understood the detailed procedures during the clinical trials. Based on this, the PMDA concluded that "the clinical trial data do not allow for a clear determination of efficacy."

However, the PMDA's report left room for consideration by stating, "Considering the limited options for COVID-19 treatment drugs, approval holds certain social significance."

This content was produced with the assistance of AI translation services.