Alzheimer’s breakthrough treatment aducanumab to be fast-tracked for approval
It could become first drug approved by US regulator for treatment of debilitating neurological condition
Scientists have discovered a drug that slows the advance of Alzheimer’s disease.
Patients given aducanumab in medical trials showed a slowdown of memory loss, an increase in awareness of time and place, and a partial reversal of speech deterioration.
After the trials' success, the US Food and Drug Administration (FDA) has fast-tracked the drug's approval from the standard 10 months to six.
Jointly made by US neuroscience specialist Biogen and Japanese healthcare company Eisai, aducanumab would become the first Alzheimer’s treatment to be approved by the US drugs regulator.
Eisai's chief executive, Dr Haruo Naito, said that this would represent a “historic milestone”.
How it works
The drug is an anti-amyloid, designed to bind to and destroy plaque that clusters around the brain’s neurons causing neurological decline.
Current treatments are merely palliative but aducanumab is administered to early Alzheimer's patients and can slow or even halt the development of symptoms.
About-face on earlier position
With about 500,000 people in the UK suffering from Alzheimer’s, the new treatment has the potential to be transformative.
Things were looking less auspicious last autumn when Biogen and Eisai ended two late-stage trials of the treatment, claiming they failed to show enough benefit to patients.
Large-scale data prompted the change of heart, which was cautiously welcomed by the Alzheimer's Society’s director of research, Fiona Carragher.
“Whilst news that the application to the US regulatory authorities has been fast-tracked should certainly give people affected by dementia a boost, the journey is not yet complete,” Ms Carragher said.
“Currently treatment options are limited so people may ask ‘What is there to be lost?’ but it’s critical we fully understand the impact and safety of this drug.”
Ms Carragher also called on the UK government to continue funding the medical research that has led to discoveries such as the Alzheimer’s gene, and other drugs that fight neurological impairments.
Updated: August 11, 2020 11:15 AM