Benzinga | Dec 17, 2021 06:44AM EST

Biogen Says 'to seek re-examination following CHMP negative opinion for aducanumab'

Biogen Inc. (NASDAQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today 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.

"For Europeans impacted by Alzheimer's disease, the lack of options to treat its early stages is felt every day. The longer we wait, the more people will progress toward more advanced dementia and we may miss the opportunity to potentially treat them," said Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. "As part of the re-examination process, we will seek to address the CHMP's grounds for refusal, with the goal of making this medicine available in the EU. European patients deserve access to innovative treatments for Alzheimer's disease."

The European Commission's regulations1 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 opinion2.

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

In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ADUHELM(r) (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 (UAE).