Aducanumab is a medication designed to treat Alzheimer’s disease developed by Biogen. It’s a monoclonal antibody designed to remove amyloid – one of the two proteins that gum up the nerves in the brains of people with the condition. Aducanumab has proven controversial in the United States, where the Food and Drug Administration’s (FDA) decision to approve the drug for use led to the resignation of three FDA advisers. Despite the approval, UA Medicare has refused to pay for Aducanumab prescriptions unless a person is on a trial.
The conflict centres around the quality of the evidence supporting the effectiveness of the drug, with Phase III studies (the EMERGE and ENGAGE trials) returning mixed results.
The Therapeutic Goods Administration is currently reviewing whether the drug should be approved for use in Australia but that may change by the time you read this as even the manufacturer is having second thoughts about the drug. In a piece published in the Medical Journal of Australia, researchers from the Melbourne Dementia Research Centre and Concord Hospital argue there are significant concerns over the drug’s efficacy and benefits.
One trial (EMERGE) did find a benefit of Aducanumab over the placebo in slowing clinical scores indicating Alzheimer’s decline when given at high doses, but the size of the effect was small, and in the other study (ENGAGE) no effect was seen. What’s more, these findings were only made during a secondary analysis of the data after the trials had been discontinued due to futility (external assessors judged that people in the trial weren’t seeing any benefit – the drugs weren’t having an effect). There were also side effects such as brain swelling and small bleeds.
The MJA article argues that adequate effectiveness of the drug hasn’t yet been demonstrated, and if the positive findings could be replicated, approval still wouldn’t be cost-effective.
This calls into question treatment strategies for dementia but the reality is that dementia research has come a long way and there are interventions which do seem to work in prevention and management of early cognitive decline.
Early Signs of dementia should not be swept to one side – find out for yourself
Tonic Media Network recently hosted a high impact webinar for GPs and General Practices about the importance of early diagnosis of dementia and the interventions that can make a difference. You can see the webinar – and we strongly encourage you to do so by going to this link. The webinar was sponsored by Dementia Australia and has been very well received.