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  • Songsong CaO

FDA grants accelerated approval for Alzheimer's disease treatment

Geat news for Alzheimer's disease patients and a satisfying outcome for Eisai and Biogen, which have been very resilient in the fight against Alzheimer's disease.


While I share the excitement of all the people around the world celebrating the full approval of Leqembi, which paves the way for CMS coverage, I can't help but worry about the uptake of the drug in the real world. Here are a few things of concern to me:


1. A boxed-warning about ARIA. I haven't done market research with physicians and patients on this particular issue, but based on my past experience working with chronic inflammatory diseases, a boxed-warning about just anything typically deals a big blow to the adoption because most physicians and patients just don't want to deal with any safety issues that could kill them faster than the disease they are trying to treat


2. Infusion every 2 weeks. This is inconvenient for patients and their caregivers for sure, even though most patients are in retirement age. Additionally, given the large patient population of Alzheimer's disease and frequency of infusion, infusion center capacity is also a concern. I'm not close to Leqembi's launch planning, but I'm sure Biogen and Eisai have thought about it


3. Confirmation of amyloid pathology prior to initiation. There are only two ways to do this - lumbar puncture and PET. Patients in the US don't like lumbar puncture, so this requirement can be an obstacle to adoption. PET is non-invasive, but the cost is high and capacity is low, given majority of the PET scans are for cancers, so I see potential delays in getting the drug initiated because of potential insurance coverage issues for PET and long wait time for the scan



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