Japan Delays Decision on Whether to OK New Alzheimer's Drug
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Tokyo, Dec. 22 (Jiji Press)--Japan's health ministry decided Wednesday to put off a decision on whether to approve a new Alzheimer's disease drug jointly developed by U.S. biopharmaceutical company Biogen Inc. and Japan's Eisai Co. <4523>.
If approved, the drug, called aducanumab, would have been the first medicine in Japan expected to fully prevent the intractable brain disorder from progressing. It is thought to be particularly effective if it is administered to early-stage Alzheimer's patients.
The ministry's Pharmaceutical Affairs and Food Sanitation Council subgroup concluded at the day's meeting that "it is difficult for now to explicitly confirm the effectiveness" of aducanumab, citing the lack of consistent results of overseas clinical trials.
The subgroup also pointed out that the association between the drug and improvement in symptoms has yet to be scientifically established and that such side effects as brain swelling and bleeding have been reported.
"The drug's effectiveness and safety should be reexamined through proper clinical trials and, depending on the results of the reexamination, whether to approve it should be discussed again," the panel said.
[Copyright The Jiji Press, Ltd.]