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FDA Gives Leqembi Full Approval

On July 6th, 2023, the U.S. Food and Drug Administration (FDA) made history by granting the full traditional approval for the use of Leqembi (Lecanemab) in the treatment of early-stage Alzheimer’s disease. This is the first drug of its kind to be approved for Alzheimer’s treatment. But despite it's unanimous approval from the FDA, Leqembi's price tag may leave

many Americans with sticker shock.

Leqembi, from drugmakers Eisai and Biogen, is the first medication that's been shown to slow the progression of Alzheimer's disease. "Today marks a breakthrough in the treatment of Alzheimer's disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable," Biogen president and CEO Christopher A. Viehbacher said in a statement.

Access is another issue, with the drug expected to be priced at about $26,500 for a typical year's worth of treatment, without insurance. The head of the Centers for Medicare and Medicaid Services, Chiquita Brooks-Lasure, pledged to "cover this medication broadly while continuing to gather data that will help us understand how the drug works" — a decision that will make it more affordable for many. Brooks-Lasure called the FDA's approval "welcome news for the millions of people in this country and their families who are affected by this debilitating disease."

Neuro-Behavioral Clinical research has long been at the forefront of Alzheimer's and Dementia Research. We owe a debt of thanks to all who worked to make this happen--with an extreme amount of gratitude for the patient volunteers and their families who make breakthroughs like Leqembi possible. We believe that all of our patients deserve access to treatment with as few barriers as possible.

While this is a tremendous step forward, our work is far from done. We won’t rest until everyone living with Alzheimer’s — at any stage — can get the treatment, care and support they need and deserve. We proudly partner with the Global Alzheimer's Platform Foundation, the Alzheimer's Association, and US against Alzheimer's in their dedication to clinical research for the future as well a care for patients and families today.

For more information about Neuro-Behavioral Clinical Research & our Memory Clinic or our international partners, please click the links below!

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