Regarding a new drug jointly developed by Eisai in Japan and a pharmaceutical company in the United States as a treatment for Alzheimer's disease, EU-European Union authorities have told EU executive agencies that "it has not been shown to be effective in treatment as a whole". I advised not to approve.
Aducanumab, a new drug for Alzheimer's disease developed by Eisai in Japan and Biogen in the United States, is a drug aimed at suppressing the progression of symptoms, and is an abnormal substance called "amyloid β" that has accumulated in the brain. It removes proteins and prevents nerve cells from breaking down.
The EU's drug regulator, EMA = European Pharmaceutical Agency, which was discussing the new drug, announced on the 17th that it has recommended that the European Commission, which has the authority to approve the EU's executive body, not approve it.
Regarding the reason, EMA said, "Although this drug reduces amyloid β in the brain, it has not been proven to be related to improvement of symptoms. Overall, it has not been shown to be effective in treating Alzheimer's disease." increase.
The drug was conditionally approved by the US FDA = Food and Drug Administration in June, resulting in a split between US and EU authorities.
An application for approval has also been submitted in Japan, and the Ministry of Health, Labor and Welfare will discuss whether to approve it on December 22nd.
Eisai "Request for Redeliberation"
Eisai commented, "Biogen will request a redeliberation of this view. We will continue to work with EU authorities to get approval for the new drug."