Japan's regulator delays Aduhelm decision, as US medics call for its market removal

23 December 2021

US biotech Biogen (Nasdaq: BIIB) and Japanese partner Eisai (TYO: 4523) today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council, which advises the Japanese Ministry of Health, Labor and Welfare (MHLW), has decided to continue deliberations on the application for the manufacturing and marketing approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease.

The news pushed Eisai’s share 8% lower to 6,477 yen by lose of trading, while Biogen was barely changed in pre-market activity.

The NDC is seeking additional data to be submitted as part of this process. The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai stress that they remain committed to bringing aducanumab to patients in Japan expeditiously.

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