Being Patient Editor in Chief Deborah Kan fields some questions from readers about a potentially forthcoming experimental Alzheimer’s drug called lecanemab, which is currently in trials and making its way toward applying for FDA approval.
By now you may have read the news of promising data on the latest Alzheimer’s drug to seek FDA approval. Lecanemab is another monoclonal antibody drug, again jointly developed by Biogen and Eisai, that the companies issued a press release claiming that the trial data they have seen so far looks promising.
After a flurry of news reports, I had quite a number of people contact me to ask what this means for people diagnosed with Alzheimer’s disease, so I am answering your questions below.
What is lecanemab, and will it cure Alzheimer’s?
Lecanamab, another “mab” or monoclonal antibody drug, is being tested to understand whether clearing amyloid plaque from the brain can actually prevent the decline in cognition in Alzheimer’s disease.
Caveat: We still don’t know whether this protein plaque is the cause of Alzheimer’s, or just a symptom.
How is it different from Aduhelm, the last disease modifying drug to be approved by the FDA and will it also be given the green light?
In principal, the drugs are similar and aim to dissolve or prevent beta-amyloid plaque from forming inside the brain. Lecanemab is targeting an earlier stage of the protein that contributes to the formation of these plaques.
Caveat: Lecanemab’s data will be presented at the CTAD conference in November, and it will apply for FDA authorization of the drug in early spring.
What exactly does this data mean for patients who have been diagnosed with mild cognitive impairment or early stage Alzheimer’s?
Good question! Translating data is still difficult to truly understand what it means for patients. The press release suggests that patients who were given the drug had their rate of cognitive decline decrease by nearly half a point (0.45) or 27 percent reduction in decline but what this actually means in terms of slowing Alzheimer’s down is still unclear. Experts also say that it may not be enough of an improvement for family members to notice a difference.
Caveat: The positive data was only announced in a press release issued by the drug companies and has yet to be assessed and published in an independent, peer-reviewed journal.
If the drug is approved by the FDA, will it be accessible to everyone?
Monoclonal antibody drugs have only been tested on people with mild cognitive impairment or patients in a very early stage of Alzheimer’s. We still don’t know what the impact may be on later stage patients. They are also quite complicated to make and have to be administered by infusion, which makes them more expensive and not as accessible to people who live in more sparsely populated areas.
Caveat: Despite Aduhelm’s approval from the FDA, the Center for Medicare and Medicaid Services (CMS) refused to pay for Aduhelm after a series of hiccups and launched its own study to seek out better data. The big question remains whether the CMS will approve reimbursements for other Alzheimer’s -mab drugs in the pipeline.
We are all hoping for better news when it comes to preventing or slowing down Alzheimer’s in its track but there’s still a lot we don’t know about whether ‘mab’ drugs are the answer to solving the Alzheimer’s puzzle.
We all wait with hope and anticipation but again, let’s not celebrate until we have better data to truly determine what is best for people with Alzheimer’s disease.