• Jiji, Kyodo


The 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.

The drug aducanumab, already sold in the United States under the name Aduhelm, 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 in 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 side effects such as brain swelling and bleeding have been reported.

“The drug’s effectiveness and safety should be re-examined through proper clinical trials and, depending on the results of the reexamination, whether to approve it should be discussed again,” the panel said.

The postponement decision came after the U.S. and European drug regulatory authorities showed split responses to aducanumab.

The U.S. Food and Drug Administration approved the drug in June on the condition that a further clinical trial is conducted. The approval was controversial, with the FDA’s outside panel declining to endorse the drug and some panel members resigning in protest.

The European Medicines Agency recommended Friday that European Union member countries refuse to authorize the drug’s marketing, on the grounds that the efficacy and safety confirmed in clinical trials were not high enough.

Aducanumab is an antibody drug designed to remove amyloid beta from the brain, whose accumulation is believed to trigger Alzheimer’s disease. Currently, the only medicines available in Japan are those that can temporarily slow the progression of the disease.

Biogen’s Japanese unit applied for the ministry’s approval last December. The remedy costs over ¥6 million per patient per year in the United States, but the price is expected to be halved next year.

Japan had about 6 million dementia patients as of 2020 and more than 60% of them suffered from Alzheimer’s disease, according to the health ministry.

More than 55 million people worldwide have dementia and the number is expected to rise to 139 million by 2050, according to an estimate from Alzheimer’s Disease International, an umbrella organization for patient support associations.

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