U.S. FDA Grants Traditional Approval to Leqembi (Lecanemab-Irmb) for Alzheimer's Disease Treatment.

BONITA SPRINGS, FL July 6, 2023 – FDA Grants Traditional Approval to Leqembi (Lecanemab-Irmb) for Alzheimer’s Disease Treatment.

In a groundbreaking move, Leqembi has received traditional approval from the FDA for the treatment of Alzheimer’s Disease. Previously approved through the Accelerated Approval pathway, Leqembi has demonstrated clinical benefit in a confirmatory trial, solidifying its efficacy and safety.

“The full approval of Leqembi signifies a historical step in the treatment of a disease that has altered the lives of millions of Americans and their loved ones,” explained Dr. Jamie Plante of Memory Treatment Centers of Bonita Springs. “We now have clinical trial data that demonstrates Leqembi can slow the progression of Alzheimer’s disease”

The drug’s mechanism of action involves reducing amyloid plaques in the brain, a hallmark of Alzheimer’s. Study 301, a comprehensive Phase 3 trial, revealed statistically significant and clinically meaningful results, with Leqembi outperforming the placebo in reducing cognitive decline.

“Through decades of Alzheimer’s research we have learned that amyloid beta plaques are an early hallmark feature of the disease and play a large role in the propagation of brain cell death, cognitive impairment and loss of memory” stated Dr. Samuel Giles of Memory Treatment Centers of Jacksonville.

The FDA’s decision represents a significant step forward in the search for effective treatments against Alzheimer’s, a debilitating condition affecting millions of Americans.

“We already have numerous current Alzheimer’s Disease patients at Memory Treatment Centers who will be treated with this groundbreaking therapy and are hopeful that we will be able to serve and treat countless more with this efficacious treatment” concluded Dr. Robert Mannel of Jacksonville.

Memory Treatment Centers are committed to finding and utilizing new and innovative treatments for Alzheimer’s and other neurological conditions, and we pleased to have full approval and continue to use Lecanemab as a tool in our arsenal. We encourage patients and their families to contact a Memory Treatment Center provider about the potential benefits of Lecanemab and other treatment options.

If you are a patient and have further questions about treatment opportunities, please contact our Bonita Springs or Jacksonville clinics.

Click to reference the full FDA release.