FDA approves breakthrough Alzheimer’s drug lecanemab

The US Food and Drug Administration (FDA) has approved lecanemab – a breakthrough drug for patients in the earliest stages of Alzheimer’s disease.

Developed by Japanese companies Eisai and Biogen, the drug will be marketed in the US under the brand Leqembi.

Lecanemab works by interacting with the immune system to clear clumps of amyloid protein in the brain.

Dr Billy Dunn, director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said:

“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.”

In a clinical trial, lecanemab was shown to ‘reduce[…] markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.”

Approximately 6.5 million people in the US suffer from Alzheimer’s disease.

Eisai estimates that 100,000 US patients would be eligible for the drug over the next three years, increasing to around 2.5 million globally by 2030.

Eric Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, Arizona, said:

“The findings provide hope for patients and families, but it is also an important step in the development of successful ways to modify and prevent the clinical onset of the disease.”

Some experts remain sceptical that the benefits of lecanemab will outweigh the risks.

Three people who enrolled in a phase III study died during the expanded phase of the trial.