Leqembi: A New Era in Medication-Based Alzheimer’s Treatment

On July 6, 2023, the US Food and Drug Administration granted approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the devastating memory-loss disease.

The drug was approved for people with early forms of Alzheimer’s disease, those with mild cognitive impairment or mild dementia who have been confirmed to have a certain type of plaque, amyloid plaque, in their brains.  Over 1 million Americans are included in the approved category, or about a sixth of the more than 6 million Americans currently diagnosed with Alzheimer’s.  It is not yet known whether the drug is effective in treating moderate or severe Alzheimer’s.

And, while many may benefit from the drug, it is not a cure.  Rather, Leqembi was shown to slow the decline in cognitive ability and functioning by over 25%.  The drug can give people in the early stages of Alzheimer’s more time to maintain their independence, do the things they love, complete their estate and care plans, and have more time to recognize and share memories with their families and friends.

That said, the drug does have side effects and requires monitoring through regular brain imaging.  About 13% of participants in a clinical trial experienced brain swelling or bleeding, and those risks could be higher for certain groups based on their genetics or if they take blood-thinning medications. 

The drug is given as an IV infusion once every two weeks and is covered by Medicare when prescribed by a physician in coordination with a clinical team participating in collecting expanded efficacy information on Medicare’s behalf.  This information will help gauge the usefulness of the medications beyond the findings of the clinical trial resulting in the FDA’s approval.

Moran Law extends its sincere gratitude to Paul Stubb, whose invaluable legal expertise and insights have contributed to the accurate and informative content of this article on the recent FDA approval of the Alzheimer’s drug Leqembi.

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