FDA approve Aducanumab in the US, targeting cognitive decline in early Alzheimer’s

Posted on the 8th June 2021

Race Against Dementia welcome yesterday’s landmark approval by the FDA of aducanumab (Aduhelm) for use in the US.

It has been nearly 20 years since the last drug for Alzheimer’s was approved and this is the first drug targeting the disease itself.  However, it is only for those with early Alzheimer’s or mild cognitive impairment.

The decision is controversial however with many differing viewpoints across the scientific community related to efficacy and cost. A stage 4 trial looking at long-term efficacy is a requirement of the license.

Prof Philip Scheltens, one of RAD’s Scientific Advisors, says:

“I welcome the FDA decision to grant Accelerated approval for Aducanumab because it stresses that Alzheimer is a life threatening, yet incurable disease, which we all knew, but is now formally acknowledged. Second, the approval is for the disease modifying effect only, i.e. removal of amyloid plaques and its precursors, acknowledging that the clinical significance of that, remains to be proven and requires longer treatment.

This approval, once also established by the MHRA and EMA, will allow expert clinicians to treat their patients on the basis of each individuals profile. RAD welcomes the progress in the field, but our work is not done: Aducanumab is not the end, just the beginning!”

Whilst this decision is positive, providing hope for those with dementia and their families, as well as an optimism for the future, it also stresses the need for urgent funding to continue research, and indeed to tackle the high percentage of preventable causes of dementia.

Further information

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