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Biogen have announced an update on the regulatory review of aducanumab in the European Union.
Dr Richard Oakley, Associate Director at Alzheimer’s Society said:
“The absence of a drug to slow down the diseases causing dementia is disappointing. In light of this new announcement it’s unlikely that the EMA will approve aducanumab as a treatment for Alzheimer’s disease next year, however we won’t know conclusively until December.
“We’ve seen huge progress over the last decade in dementia research, and aducanumab is not the only drug in the pipeline. We need to maintain this momentum: the Government must honour their commitment to double dementia research funding so that we can bring desperately needed treatments to the 850,000 people living with dementia in the UK.”
David Thomas, Head of Policy at Alzheimer’s Research UK, said:
“We urgently need new treatments for Alzheimer’s disease, but it’s vital that regulators judge that any new treatment is safe and effective. Results of aducanumab’s phase III trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment.
“The FDA’s approval of aducanumab in the US June was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives.
“The European Medicines Agency is now undertaking its own review of the data and it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS will be ready to deliver them in the years ahead.”
Prof Robert Howard, Professor of Old Age Psychiatry, UCL Division of Psychiatry, said:
“This is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.
“The FDA’s Accelerated Approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its Staff.
“I would anticipate that EMA, when they meet in December, will not grant a license to aducanumab. Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA should not approve a license for aducanumab.”
Declared interests
Prof Robert Howard: “I don’t have conflicts of interest.”
None others received.