In exciting news for the dementia field, it has today been announced by Biogen and Eisai that there are plans to pursue US regulatory approval for aducanumab for the treatment of early Alzheimer’s disease. The news follows new analysis of a larger dataset from Phase III studies that has showed significant slowing of clinical decline.
The announcement will come as a surprise to many in the field as, in March earlier this year, the companies released disappointing news that they were to discontinue the Phase III trials of the drug, with no significant improvements observed. However, following new analysis in consultation with the Federal Drug Administration (FDA), it appears that the Phase III EMERGE study met its primary endpoints in showing a significant reduction in clinical decline, in a subset of people who received sufficient exposure to a high dose of aducanumab.
Those that received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language, and benefits on activities of daily living including conducting personal finances and performing household chores. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and first to demonstrate that removing amyloid beta resulted in better clinical outcomes.
UK DRI Director, Prof Bart De Strooper, said:
“It is fantastic to hear of these new positive results emerging from the aducanumab trials. We currently have no effective treatments to slow or halt the progression of Alzheimer’s disease and I hope this signifies a turning point.
It is encouraging for the field that the tremendous work delivered to target amyloid beta appears to be validated in this trial and we should now redouble our efforts to tackle this central problem in Alzheimer’s Disease, alongside other important contributors.
The results demonstrate that evaluation of our trial strategies and analysis must be ongoing. As with other medicines, there are subtle but critical differences between individuals, and this can have a huge effect on response to treatments.”
For more details on the announcement and next steps, please see the official press release from Biogen.