FDA’s decision to approve aducanumab for the treatment of Alzheimer’s disease

Date: 2021-06-08

The US Food and Drug Administration (FDA) communicated yesterday its decision to approve the investigational drug, aducanumab, for the treatment of Alzheimer’s disease. This is encouraging news for the millions of patients in need of disease-modifying treatments for this debilitating disease.

Aducanumab is an immunotherapeutic drug candidate that binds to and removes clumps of amyloid beta (a small part of a larger protein) found in the brains of Alzheimer’s patients. These clumps (also known as plaques or aggregates) are believed to damage brain cells, leading to the onset and progression of Alzheimer’s.

Oligomers are a subset of amyloid beta aggregates in the brain, which are far more toxic. It is not known to what extent aducanumab and other plaque-targeting therapies are able to neutralise oligomers. So, although it is encouraging that aducanumab has shown some positive effects and signs of clinical benefit in two large Phase 3 studies, we believe that a therapy that is more selective towards the more toxic forms of the aggregates will ultimately prove to be more effective at stopping the progression of disease.

Our lead candidate, ALZ-101, is a highly specific, therapeutic vaccine that specifically targets neurotoxic oligomeric amyloid beta. Besides the specificity – which should result in better efficacy and fewer side effects – vaccines as a mode of treatment offer additional advantages such as fewer booster doses and are more cost effective.

Yesterday’s decision provides confirmation and encouragement that we are on the right track when it comes to targeting amyloid beta. We are confident that the science in this area is advancing and that therapies are on the horizon that will benefit patients even more. More importantly, it provides hope to the millions of people around the world who are suffering from this horrible disease.

Click here to read more about the FDA’s decision on the accelrated approval