The non-approval of aducanumab in Europe still marks a significant stride forward in dementia research
An opinion piece by Professor John O’Brien, NIHR Clinical Research Network National Specialty Lead for Dementias
The European Medicines Agency (EMA) has today said no to approving aducanumab – a new drug to treat Alzheimer’s disease.
EMA considered that although the drug removed amyloid, a toxic protein that builds up in the brains of people with early stages of Alzheimer’s disease, there wasn’t as yet good evidence this led to clinical benefits. In addition, there were significant side effects.
Although this will be disappointing news to people with Alzheimer’s disease and their families and carers, this is a landmark decision.
It is the first time that a disease modifying therapy for any type of dementia has had sufficient evidence to apply for approval. Indeed, Biogen, the manufacturer of the drug, can ask for EMA’ s decision to be re-examined.
Having evidence from well conducted clinical trials was essential to allow the EMA to make a well informed decision, and further studies will be undertaken to gain more insights.
Evidence like this, can only be gained by the involvement of people in research, and several sites in the UK and Join Dementia Research made this possible. 25 people took part in the UK clinical trials after being matched through Join Dementia Research – which equates to 30% of participants in the UK.
Although the clinical benefit wasn’t considered by EMA to be clear, the fact the drug caused removal of amyloid from the brain is a very important proof of concept in the search for new treatments.
Today’s decision renews the need for further research to find effective treatments and we have reason to be optimistic as there are over 100 different compound drugs in clinical trials taking place worldwide.
It is not yet known whether Biogen will submit a separate application for approval to the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
However, it is now becoming increasingly clear that it is a case of “when” not “if” a disease modifying therapy will become clinically available.
Greater participation in research, through Join Dementia Research, is a key way we can speed up this time and get treatments sooner.