Evidence considered at FDA Advisory Committee for potential first new Alzheimer’s disease treatment in decades

The US Food and Drug Administration has reviewed clinical trial data for Biogen’s drug aducanumab, which aims to treat cognitive and functional decline in Alzheimer’s disease.

Today, the US Food and Drug Administration (FDA) convened an Advisory Committee meeting to review clinical trial data for Biogen’s drug aducanumab – developed for treating cognitive and functional decline in Alzheimer’s disease. Unfortunately, the debate couldn’t reach a conclusion and the case will now be referred back to the FDA. At this stage it is hoped that further evidence can be provided with a further announcement in the new year.

If approved aducanumab would be the first new treatment in almost 20 years and the first to offer hope that the treatment could change the progression of the disease; not just the symptoms.

At this time Biogen has confirmed that it has also filed for approval in Europe and Japan, with timelines to be confirmed.

Paola Barbarino, Chief Executive of Alzheimer’s Disease International (ADI), commented on the Advisory Committee’s decision: “We have been awaiting news on a drug treatment breakthrough for Alzheimer’s disease for almost 20 years and following this Advisory Committee meeting we wait again, with cautious optimism, for the final FDA findings in the new year.

“Drug treatment development for Alzheimer’s disease and other dementias is such a complex process but we take great encouragement from today’s committee meeting. Huge progress is being made and regardless of the outcome great strides are being taken in both treatment and diagnostic research.

When treatments do become available it is essential that healthcare systems are prepared, especially in tackling the difficult area of diagnosis, and it is crucial to have transparency around access and cost.

Dr Serge Gauthier, Director of the Alzheimer Disease and Related Disorders Research Unit of the McGill Center for Studies in Aging and Professor in the Departments of Neurology & Neurosurgery, Psychiatry, and Medicine at McGill said: “It is appropriate that the FDA carefully reviews all aspects of the safety and efficacy of what could be the first disease modifying drug for Alzheimer’s disease and we look forward to the FDA final decision.” 

Currently over 50 million people are living with dementia, with a new case every three seconds. This number will increase to 152 million by 2050. The annual global cost of dementia is US$1trillion annually, which is forecast to double by 2030.

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