On Thursday, July 6, Leqembi® (lecanemab – irmb), became the first beta-amyloid targeting medication for the treatment of Alzheimer’s disease to receive full approval from the U.S. Food and Drug Administration (FDA). The drug, from pharmaceutical companies Eisai and Biogen, received conditional approval this past January based on early results from a clinical trial. The FDA’s full approval was based on a review of data from the completion of a much larger, 1,800 person clinical study.
Leqembi® is the first disease modifying treatment to receive traditional FDA approval. The drug works by targeting and clearing beta-amyloid plaques from the brain. In the data reviewed by the FDA, as compared to the placebo group, the drug slowed the rate of cognitive decline by 27% in those with Mild Cognitive Impairment (MCI) and Early-Stage Alzheimer’s disease with evidence of amyloid plaque buildup as confirmed by an imaging scan. The drug is given intravenously every two weeks at an infusion center.
“This is an exciting milestone for Alzheimer’s research and gives hope to thousands of families impacted by this life changing disease,” said Ken Zaentz, President and CEO of Alzheimer’s New Jersey®. “The gift of even just a little more time for persons with Alzheimer’s to connect with those they love can mean so much to families. The approval of Leqembi® also further supports the importance of getting an early and accurate diagnosis and the value of participation in clinical research, as science continues to develop other treatments for Alzheimer’s,” said Zaentz.
The FDA approval included a black-box warning noting that the drug carries the risk of certain side effects including amyloid-related imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolve over time but, in rare cases, can be fatal.
According to Zaentz, “it is also extremely important to understand that the Leqembi® is not a cure nor is it a drug appropriate for everyone who has Alzheimer’s disease. An open and frank discussion and analysis that includes the physician, the person with Alzheimer’s disease and the primary caregiver is vital to match the treatment to the person who will have the greatest opportunity for benefit with the least risk. Even for those who qualify for Leqembi® the decision to take the drug can be a very personal one with the ultimate measure of success different for each family.”
Shortly after the announcement of FDA approval of Leqembi®, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare will cover the treatment. Several conditions apply for coverage: 1) enrollment in Medicare, 2) a diagnosis of MCI or mild Alzheimer’s disease with documented evidence of beta-amyloid plaque on the brain and 3) having a physician who will participate in a qualifying registry with an appropriate clinical team and follow-up care to continue to gather data on the drug.
For more information, contact the Alzheimer’s New Jersey Helpline at 888- 280-6055.
