ESALY Eisai Company Ltd (PK)

By Chris Wack

Biogen Inc. and Eisai Co. Ltd. said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application for aducanumab.

Aducanumab is intended to be used for the treatment of the early stages of Alzheimer's disease known as mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.

This decision is aligned to the negative trend vote of the committee in November. Biogen said it would seek a re-examination of the opinion by the CHMP.

The European Commission's regulations allow an applicant to request a re-examination of a CHMP opinion, followed by submission of documentation with detailed grounds for the request. The committee has 60 days after receipt of this documentation to re-examine their opinion.

The MAA included efficacy, safety and biomarker data from a global, multistudy clinical development program which included 3,600 patients in more than 20 countries.

In June, the U.S. Food and Drug Administration granted accelerated approval for Aduhelm aducanumab-avwa 100 mg/mL injection for intravenous use as the first Alzheimer's disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. Aduhelm is also approved in the United Arab Emirates.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

December 17, 2021 07:45 ET (12:45 GMT)

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