Aduhelm (aducanumab) faced another rejection from Japanese regulators after EU refusal

Aduhelm was approved by the FDA in June 2021 for treatment of Alzheimer's disease. On December 22, 2021, Biogen and Eisai announced that the first Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare (MHLW) has refused to approval Aduhelm. The Committee ruled that existing clinical evidence was insufficient, and that additional clinical data was required for further review. The two manufacturers are currently working with Japanese regulators to settle on specific additional data needed. (1)

Aduhelm’s news from Japan came approximately a week after its rejection from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to authorize the drug. The EU drug regulators noted that the relationship between Aduhelm’s clinical benefit of reducing amyloid beta and Alzheimer’s clinical improvement has not been established. In addition, the Agency also stated concerns towards potentially serious adverse effect of amyloid-related imaging abnormalities. (2)

Biogen and Eisai are now circling back their focus on the U.S. market, where they are awaiting the Centers for Medicare & Medicaid Services (CMS) decision to cover Aduhelm on Medicare formulary in January. In anticipation of this important decision, Biogen has decided to halve the drug price, resulting in an annual cost of $28,200 for a patient weighting 74 kg (163 pounds) beginning of 2022. (3)