BACK in June, the US Food and Drug Administration approved aducanumab (Aduhelm) for the treatment of Alzheimer’s – the first in nearly two decades and, crucially, unique in showing signs of slowing disease progression.
For the millions affected, this landmark decision offered a rare moment of hope in the shadow of this devastating condition.
Another decision is hanging in the balance – the advisory committee for the European
Medicines Agency will announce its verdict next week on whether aducanumab should also receive approval in the European Union.
However, early indications suggest not. This may feel unfair for those living with Alzheimer’s in the EU, but the US approval process for aducanumab has been highly controversial.
The FDA, despite uncertainties, granted a licence on condition that monitoring and further trials are carried out by 2030.
This decision is based on biological flags called biomarkers showing significant clearance of the toxic protein amyloid beta from the brain, which they think will lead to improvements for the patient. For many there is insufficient evidence to draw these conclusions, and with added concerns over safety, and an annual cost of $56,000, the approval represents a big gamble.
Despite all the controversy surrounding aducanumab, I feel the decision for US approval is a substantial milestone in the development of effective treatments.
In the initial stages of Aids research, drugs also showed poor efficacy.
But biomarkers were utilised to fasttrack treatments, crucially streamlining the approval process and galvanising investment. Diagnostic research tools, like those developed at the UK Dementia Research Institute, mean we can now do the same for Alzheimer’s.
By taking a smart approach we can monitor drug effects, identifying people at the earliest stages of disease and harnessing this opportunity to gain invaluable knowledge.
If the EMA does not approve aducanumab it is likely the UK, regulated by the Medicines and Healthcare products
Regulatory Agency, will follow suit. I know this would be disheartening for so many people, and us scientists, but these latest developments represent a turning point in our race to find cures for dementia.
Off the back of the US approval two more treatments – donanemab and lecanemab – have been granted “breakthrough therapy” designation to speed up development and review.
There is real momentum in the field, and with sustained investment I am hopeful for life-changing treatments in the not-so-distant future.