Japan withholds approval of Alzheimer's drug

NHK -- Dec 23
A panel of experts advising Japan's health ministry has pushed back its decision on approving a new Alzheimer's drug developed jointly by US and Japanese companies.

The firms say Aducanumab is the first medicine that inhibits progression of the disease, rather than just slowing the development of symptoms.

"It is difficult to judge the effectiveness of the drug based on data available at this point. We need to evaluate its effectiveness and safety based on the results of verification tests to be conducted in the future. We will have to discuss the results again," a ministry official said.

The panel cited inconsistency in the results of the final stage of clinical trials. They also noted swelling and bleeding in the brain of patients who received the drug.

It was developed by the US company Biogen and the Japanese firm Eisai.

They say the drug removes deposits of a protein called amyloid beta in the brain.

The firms say the medication delayed cognitive decline in international clinical trials by 22 percent.

The US Food and Drug Administration conditionally approved the drug in June.

But the European Medicines Agency said last week Aducanumab should not be authorized in the EU.

アルツハイマー病の原因物質を抑える新薬は承認が見送りとなりました。  厚生労働省の審議会は日本の製薬大手「エーザイ」とアメリカの医薬品大手「バイオジェン」が共同開発したアルツハイマー病の治療薬「アデュカヌマブ」について、承認を見送ることを決めました。 - ANNnewsCH