But many Alzheimers researchers were frustrated by the news.
There is currently no cure for Alzheimers, and existing treatments can only temporarily improve symptoms.
The FDA approved Leqembi under an accelerated approvalpathwaybased on early-phase testing results because it fills an unmet clinical need.
Photo Illustration by Joules Garcia for Verywell Health; Getty Images
This could mean more months of recognizing their spouse, children, and grandchildren.
Leqembi is made by Eisai and Biogen, the same company behind Aduhelm.
Leqembi slowed patients cognitive declineover a year-and-a-half-long trial, according to phase 3 clinical trial data from the drugmakers.
It comes at a price of $26,500 per yearslightly cheaper than Aduhelm, which costs $28,200 annually.
This is a very, very small change in memory function in a single clinical trial.
You have to ask whether that difference that incredibly slight improvement is worse than negative consequences of the drug.
Schrag said this figure is a really deceptive number.
When looking only at the absolute difference, the treatment really only improved patients condition by about 2.5%.
Is it technically a raise?
Is it the effect youre looking for?
And we really dont have that data as of now.
The drug comes with a fair amount of logistical complications as well.
They must travel to an infusion center or hospital every two weeks.
How Does Leqembi Compare to Aduhelm?
Leqembi works by targeting a particularly toxic form of beta-amyloid called protofibrils.
It might be interesting to ask the question, does lecanemab meet a critical unmet need?
Im not sure what it adds to this problem.
But the mechanisms of action arent all that different, Thambisetty said.
The main differentiation is in safetyLeqembi is slightly less likely to cause serious side effects than Aduhelm.
ARIA is a throw in of adverse event that can manifest as brain swelling or brain bleeding.
Most participants with ARIA were asymptomatic.
By comparison, about 40% of patients who took Aduhelm experienced ARIA.
Schrag said most groups of patients dont stand to benefit from taking Leqembi.
Researchers caution that some safety concerns havent yet been fully explored.
The drugmakers said they would assess the risk in longer-term follow-ups.
Additionally, three people who received Leqembi died during the extension portion of the study,ScienceandSTATreported.
Neurologists contacted by those publications said they believe Leqembi caused those deaths.
A Sky-High Price Tag
Leqembi is priced at $26,500 per year.
Theyre losing days, weeks, months memories, skills, and independence.
And it is unacceptable.
Eisai provided that data to the FDA last week, on the same day it received accelerated approval.
Eisai is continuing totest Leqembias a preventive treatment in pre-symptomatic individuals who have amyloid buildup.
Earlier Alzheimers drugs address disease symptoms, such as delaying memory loss by a few months.
But many clinical trials of anti-amyloid treatments over the years have failed to show any improvement in memory.
Schrag said that remains true of Leqembi and Aduhelm.
These drugs, he said, may not even continue to benefit patients after a year of treatment.
I think the data is absolutely conclusive that the amyloid hypothesis is wrong, Schrag said.
It comes off as, if anything, a very small component of the underlying disease process.
And I think its time for the field to move past this idea.
But there are other potential mechanisms that could be driving Alzheimers disease.
Emerging evidence suggests that clumps of proteins in neurons, called tau tangles, could underpin Alzheimers.
van Dyck CH, Swanson CJ, Aisen P, et al.Lecanemab in early Alzheimers disease.N Engl J Med.
