Lecanemab.
Is it really working?
So, the data seems to indicate that administering this drug will retard cognitive and functional decline by 27%, when compared to a placebo. That’s good news for Eisai and Biogen- as well as perhaps for Eli Lilly which is concurrently testing its own anti-amyloid drug for Alzheimer’s.
Besides the popular press, the results were published in the New England Journal of Medicine (article by Dr. CH van Dyke at Yale, along with 18 of his compatriots. [Lecanemab in Early Alzheimer’s Disease.])
There are still problems with the drug. First of all, these drugs are relying on the model that amyloid formation is a critical issue in Alzheimer’s. Oh, and two of the study participants died during the trials, and about 1/5 of the participants developed brain swelling.. Then let’s top it off that a 0.45 difference on an 18 point cognitive scale may not be clinically meaningful.
(That is true, especially considering what we discussed on Friday. Wine, tea, and some vegetables were able to provide about the same change in cognitive decline as this drug.)
The amyloid debate as a keystone of Alzheimer’s is still ranging. Some folks are convinced that amyloid plaque is the key factor in Alzheimer’s, while others recognize that its eradication does not reverse Alzheimers. (That is part of the reason that Medicare elected to not pay for Biogen’s other anti-amyloid drug (Aduhelm, about which much controversy reigns).
So where does that leave investors? Biogen’s stock has maintained a roughly 50% gain since the late September press release. That is despite the underwhelming clinical effect, the safety concerns and the very real debate over whether the Centers for Medicare and Medicaid Services will decide the data are strong enough to override a prior stance on amyloid treatments. The CMS made a rare decision this year not to pay for Biogen’s earlier anti-amyloid, Aduhelm.
As such, we are down to two key questions- which may just be the opposite side of one. Will the government pay for a drug that seemingly lowers amyloid levels? And, will our docs even prescribe such medication.
