Photo/Illutration A health ministry official on Dec. 22 announces a decision by the ministry’s expert panel to continue discussing whether to approve the use of aducanumab as a treatment for Alzheimer's-type dementia. (Kai Ichino)

A health ministry expert panel deferred approving the use of aducanumab as a treatment for Alzheimer's-type dementia, citing a need for more data on the drug’s efficacy through a clinical trial that will take years. 

The intravenous drug, jointly developed by the major Japanese pharmaceutical firm Eisai Co. and the leading U.S. drug company Biogen Inc., is the first of its kind that the developers say can directly address the cause of the debilitating disease.

The panel on Dec. 22 decided to continue discussing whether to grant manufacturing and marketing approval to aducanumab because it is difficult to assess the drug’s efficacy based on current data, according to the ministry.

The panel will deliberate on the matter again after the results of an additional clinical trial are submitted, but the process will take years, said the ministry.

Expectations are high that the drug could slow the progression of Alzheimer's-type dementia if it is administered to patients at an early stage.

Eisai and Biogen applied for approval for the use of aducanumab in Japan last December.

They say the drug can inhibit a buildup of abnormal proteins called amyloid beta in the brain, which is believed to cause dementia.

But the panel said it is not clear that a drop in the amount of amyloid beta can help slow a decline in cognitive functions since that is not the case for some patients.

The panel also pointed to a lack of consistency in submitted data from clinical trials, saying the administration of aducanumab made little difference in the progression of the disease in one of the two clinical trials.

The panel determined that it is necessary to re-assess the drug’s safety and efficacy since swelling in the brain was observed in about 35 percent of participants who received the drug in the clinical trials.

Some 50 million people suffer from dementia around the globe, while the number is roughly 6 million in Japan. Seventy percent of the patients are thought to have Alzheimer's-type dementia.

Aducanumab is seen as a promising treatment for the disease as countries, particularly advanced nations, face the problem of aging populations.

But regulatory authorities in the United States and Europe made different decisions on whether to authorize the drug.

The U.S. Food and Drug Administration gave the green light in June, but it also noted that it may revoke the approval unless an additional clinical trial shows the drug’s efficacy.

This month, the European Medicines Agency decided not to authorize the drug in the European Union, saying its benefits do not outweigh the risks.

Eisai and Biogen said they plan to start an additional clinical trial next year and expect that it will take four years before key assessments are completed.

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