Aduhelm was released last year. It was the first new Alzheimer's drug approved by the FDA in almost two decades, but it was mired in controversy, with many experts saying there wasn't enough evidence to support its efficacy. The drug was limited by Medicare.
You would be forgiven for questioning what appears to be a promising development in Biogen's Alzheimer's drug development given last year's Aduhelm spectacle. That's what it announced with a partner on Tuesday. Initial data shows that the new drug is doing well in late-stage clinical trials so that Biogen might have a redemption arc.
lecanemab is an anti- amyloid medication. A normal form of the amyloid is produced by the brain. An overabundance of amyloids is believed to be caused by a disruption in a healthy brain's built-inprotein disposal system, resulting in a plaque; although our understanding is still fuzzy, brains with Alzheimer's are shown to have abnormal plaque levels.
According to The New York Times, Biogen and Eisei tested nearly 1800 people with mild to moderate Alzheimer's. 27 percent of lecenameb patients showed a reduction in cognitive decline when compared to the placebo group at the end of 18 months of treatment. Those aren't completely game changing results, but they are a striking figure in this area, where pharmaceutical progress has often seemed stagnant.
There are some things to keep in mind. Some patients in the study experienced brain swelling or even bleeding, and some experts are concerned about the study's significance. Ivan Cheung, the chairman and chief executive of Eisai, claimed in a Tuesday press conference that this is the first positive large clinical trial to show that you can slow down Alzheimer's disease at this very early stage.
This drug only targets the very early stages of Alzheimer's. The quicker a disease is caught and treated the better. There is enough intrigue to warrant further study, even though 0.45 out of 18 is not much. The drug is being pushed for FDA approval. More detailed results will be published in November and the FDA will make a decision in January.
"Today's announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease and provide a clinically meaningful impact on cognitive and function," said Mr. Vounatsos. We believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion with the patient, scientific, and medical communities.
Alzheimer's is known for its brutality and lack of treatment. It is exciting to see what appears to be a somewhat significant moving of the needle in what has been a multi-billion dollar sea of largely disappointing research. They hope they have it right this time.
There are allegations of decades of Alzheimer's research being based on fabricated data.