FDA Grants Full Approval For New Alzheimer’s Disease Treatment

July 28, 2023

Lecanemab, a therapy that targets amyloid proteins thought to cause Alzheimer’s disease, has been granted full approval by the Food and Drug Administration (FDA), a decision that will result in greater access to the treatment.

Lawrence Sterling Honig, MD, PhD

Lawrence Sterling Honig, MD, PhD

“Lecanemab, marketed as Leqembi, is the first drug for Alzheimer’s disease to receive approval on the basis of clinically slowing the progression of Alzheimer’s disease,” says Dr. Lawrence S. Honig, a neurologist at NewYork-Presbyterian/Columbia University Irving Medical Center. “Full approval is a major step forward.”

The Centers for Medicare & Medicaid Services (CMS) has indicated that the medication will be covered after this latest approval as long as the prescribing physician and clinical team provide information about patients in a privacy-protected registry, “a database designed to collect information about how the drug works in the real world,” adds Dr. Honig. [read more]

Source: NewYork-Presbyterian Health Matters