News
CHMP negative on MAA for Aduhelm for Alzheimer's disease.- Biogen + Eisai
Biogen Inc. and Eisai Co., Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease known as mild cognitive impairment (MCI) 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 2021. Biogen will seek a re-examination of the opinion by the CHMP.
Condition: Alzheimers
Type: drug
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