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The Peripheral and Central Nervous Systems Drug Advisory Committee met to discuss key questions about the efficacy and safety of the immunotherapy aducanumab for the treatment of Alzheimer’s. Voting suggested the evidence did not support its effectiveness for the treatment of Alzheimer’s disease, and uncertainty on whether there was strong evidence of a pharmacodynamic effect on Alzheimer’s disease pathophysiology.
Prof Gordon Wilcock, Emeritus Professor of Geratology, University of Oxford, said:
“I am not at all surprised that despite submitting more than two and a half million pages of data and information Biogen received an almost unanimously negative response about efficacy from the advisory committee. The data that I have seen is, in my opinion, inadequate to counter the earlier negative trials of aducanumab and is based on a post hoc evaluation of some of the data from these trials.”
“It is extremely important that the FDA make a decision based on science rather than urgency or people with Alzheimers will suffer even more harm.”
Prof Bart De Strooper, Director of the UK Dementia Research Institute, commented:
“We still don’t know what the FDA’s final decision will be on aducanumab as a treatment for Alzheimer’s disease, but what is certain is that a treatment is desperately needed and the wait for one has been very long indeed.
“It would be of great interest to see whether clinical benefits would be seen in a long-term study where amyloid beta in the brain was significantly lowered over a long period. It is unfortunate that this trial was never completed and it will be interesting to see if Biogen will decide to restart and complete this study if there is no positive decision from the FDA in March.
“Perhaps one useful outcome of this is that a light has been shone on some of the challenges in the field of dementia research. Trials are long and expensive and getting approval for new treatments is not easy. There are still no approved disease-modifying drugs, and it is 17 years since any new drug was approved to treat symptoms of Alzheimer’s disease. Dementia research needs to be funded and supported into the future if we are to make a breakthrough, and this is more urgent than ever now when studies have been disrupted and funding streams are drying up as a result of the pandemic.
“It may be worth considering new and different ways of trialling and approving treatments in future. At the UK Dementia Research Institute, we are constantly looking at how to improve and speed up trials so that the wait for an effective treatment can be over as soon as possible for the 850,000 people in the UK living with dementia.”
Samantha Benham-Hermetz, Director of Policy and Public Affairs at Alzheimer’s Research UK, said:
“People affected by Alzheimer’s disease have waited a long time for a life-changing treatment and yesterday’s (Friday 6 November) advisory committee hearing was an important step in the FDA’s process for considering whether aducanumab could be the drug to end that wait.
“The committee heard from people living with Alzheimer’s disease who spoke powerfully and movingly about the devastating impact of the condition on their lives, and sometimes generations of their families.
“The final decision is yet to be made about whether aducanumab is safe and clinically effective to be licensed in the US. But the committee will now need to review the evidence.
“While we await the outcome of this process, alongside many people affected by dementia, Alzheimer’s Research UK will continue work highlighting the need for new treatments for dementia to be made available without delay to the people who need them.”
Declared interests
Prof Gordon Wilcock: “I don’t have any conflicts of interest.”
Samantha Benham-Hermetz: “Nothing to declare.”
None others received.