Biogen Inc. will ask U.S. drug regulators to approve new Alzheimer’s drug, Alzheimer’s Society responds
Biogen Inc. will ask U.S. drug regulators to approve the company’s experimental Alzheimer’s therapy, reviving the nearly abandoned treatment, after a new analysis of data from two failed clinical trials showed promising results.
In March, the company said a major trial of the drug, aducanumab, had been a failure.
But new analysis from Biogen looked at data from the two final-stage trials of more than 3,000 patients, where a subset were treated with the highest dose of aducanumab, had what the company said was a statistically significant slowing of decline of cognitive ability and basic activities of daily living.
Dr James Pickett, Alzheimer’s Society Head of Research said:
'This is hugely exciting news. After the trial being stopped earlier this year because it appeared not to work, further analysis suggests that it does benefit people with dementia in the earliest stages.
We’re waiting for further data but this could be the first new treatment for Alzheimer’s disease in over 15 years, and as such, has the potential to be a transformative discovery.
'Alzheimer’s Society has a proud history of funding dementia research, including critical discoveries that have made today’s news possible.
'We will work alongside the company, regulators and people affected by dementia to understand the difference this could make to families and, if appropriate, to ensure people can benefit from this medical breakthrough in the future'.
UK Dementia Research Institute (UK DRI)
As a founding charity partner for the UK Dementia Research Institute, Alzheimer’s Society has pledged £50 million towards the single biggest investment in dementia research the UK has ever seen.