Aducanumab – how excited should we be?
Joel Petch, Senior Lecturer in Mental Health and Clinical Science, discusses the potential of a new drug to assist in the treatment of Alzheimer’s disease.
This week, Biogen, an American pharmaceutical company filed an application to the US Food and Drug Administration (FDA) for the drug Aducanumab to be licenced as a therapeutic agent for Alzheimer’s disease (AD). If approved, Aducanumab would become the first medication licenced for the treatment of AD in the past decade; and approval in the US could lead the way to UK approval.
AD remains the leading cause of dementia – an umbrella term for progressive and irreversible brain conditions with marked tissue loss within the brain.
Current treatment options for AD include evidence-based pharmacological agents, including acetylcholinesterase inhibitors and glutamatergic antagonists; although, currently approved medications are considered to slow the progression of the disease, as opposed to reverse the disease and associated clinical decline, as has been stated by Biogen regarding Aducanumab.
So, is Aducanumab the AD miracle drug that we’ve been waiting for? Possibly, but probably not, and here’s why.
Aducanumab is, actually, not a new drug; and a number of previous trials have failed to demonstrate meaningful improvements, when compared to placebo. This lack of response to Aducanumab actually led to Biogen’s own phase three trails being discontinued in early 2019, which makes the latest claims from Biogen even more surprising.
This has been attributed to a higher than initially thought dose being required, as well as the duration of exposure to Aducanumab being influential. This was only detected following an extensive, retrospective data trawl by Biogen. This has been referred to, by Biogen, as due to an incorrect analysis earlier within the year. However, if the drug is as effective as is now being stated, the discrepancy between the interpretations of data is somewhat surprising.
If the data provided by Biogen, which still requires robust and independent statistical analysis, does demonstrate that Aducanumab offers clearance of the accumulations of Aβ- this could be a significant advancement within our understanding of what is without a doubt a devastating disease. It is exciting that there is renewed scientific and pharmaceutical interest within the area of AD, something which has reduced over recent years, often considered to be due to the complexity of AD.
Currently, whilst we are awaiting further analysis of the data and Biogen’s formal application to the FDA, it may be prudent not to get too excited regarding the potential of Aducanumab; an easy trap to fall in to, particularly given the paucity of optimism related to new drugs within the field over recent years. For now, it is important to be optimistic, but we must be realistic also.
Joel Petch is a senior lecturer in mental health and clinical science within the Faculty of Health and Wellbeing. Joel’s clinical interests include the interface between physical and mental ill-health, psychoneuroimmunology, psychopharmacology, and structural neuroimaging. Joel can be founding discussing most things neuro-related on Twitter @joelpetch