FDA approval of Alzheimer drug welcomed by ASI

A decision by the US Food & Drug Administration (FDA) to approve a new medication  for the treatment of Alzheimer’s disease has been welcomed by the Alzheimer Society of Ireland (ASI).

The FDA approved Leqembi via its accelerated approval pathway, which in certain circumstances, allows it to approve drugs faster.

Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. According to the FDA, these medications “represent an important advancement in the ongoing fight to effectively treat Alzheimer’s”.

While the specific causes of Alzheimer’s are still not fully understood, the disease is characterised by changes in the brain, including the development of harmful amyloid beta plaques, that result in loss of neurons and their connections. These changes affect a person’s cognitive skills.

In clinical trials, patients receiving Leqembi had significant dose- and time-dependent reduction of amyloid beta plaques.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” explained Dr Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

The ASI described this news as “hugely positive”. There are currently around 64,000 people in Ireland with dementia and this figure is expected to jump to 150,000 by 2045.

Leqembi’s accelerated approval was based on phase II trial data, but in recent months further data from a large phase III trial was presented by the Japanese pharmaceutical company, Eisai, at the annual Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco. This data supported the earlier results and provided more information on the potential benefits of the drug. 

“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. 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,” commented ASI research and policy manager, Dr Laura O’Philbin.

However, she emphasised that there is “still a way to go” as the drug will still need to go through the FDA’s traditional approval process and it will not be suitable for everybody.

However, she added that this is still “a hugely positive and significant step closer to a credible treatment option for mild cognitive impairment and early Alzheimer’s disease”.

For more information on the FDA’s decision and its accelerated approval pathway, click here.