The US Food & Drug Administration’s (FDA) decision to approve the Lecanemab antibody, which will be sold under the name Leqembi, has been welcomed by the Alzheimer Society of Ireland (ASI).
Leqembi targets the brain’s harmful amyloid beta protein under their accelerated approval pathway, and data suggests that it may be able to halt the progression of Alzheimer’s disease.
Leqembi’s accelerated approval was based on data from a Phase II trial, but more recent data from a large Phase III trial was presented at the annual Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco by the Japanese pharmaceutical company Eisai.
This data supported the earlier results and provided more information on the potential benefits of the drug.
Responding to this promising news, the ASI research and policy manager Dr. Laura O’Philbin said: “The FDA’s decision to grant accelerated approval of Leqembi is a hugely positive and significant step closer to a credible treatment option for Mild Cognitive Impairment and early Alzheimer’s Disease.
‘In Europe, we expect Eisai to file for marketing approval with the European Medicines Agency by March this year. The world is watching and waiting, and there is no denying that we have entered into a hugely exciting time in the treatment of Alzheimer’s Disease, with news of other drug therapies also expected this year”.
“It’s important to remember that we still have a way to go as Leqembi will need to go through the FDA’s full traditional process and that this drug will not be suitable for everyone. The Alzheimer Society of Ireland looks forward to continuing to support all people affected by dementia.”
In Ireland, there are currently an estimated 64,000 dementia sufferers, and by 2045, there are expected to be 150,000.
Some six million people in the US and many more worldwide have Alzheimer’s, which gradually damages brain regions required for memory, reasoning, communication, and daily tasks.
The FDA’s approval was based on one mid-stage study involving 850 individuals with early-stage Alzheimer’s who also had positive tests for a particular type of brain plaque, which is a hallmark of the illness.