A new treatment for patients with early stage Alzheimer’s has been approved, despite some concerns about its safety.
This week, the U.S. Food and Drug Administration approved Eisai and Biogen’s Leqembi through an Accelerated Approval pathway. This early approval is for drugs that address unmet needs and show evidence of possible benefits to patients. However, companies are still required to conduct further clinical trials to confirm the benefits.
The approval came after a Phase 3 trial which involved 856 Alzheimer’s patients with mild cognitive impairment or mild dementia and amyloid beta plaques. The results showed that patients who took the approved dose of 10 milligram/kilogram every two weeks had statistically significant reduction in amyloid beta plaque through week 79, compared to placebo, which showed no reduction. The drug was also linked with moderately less decline in cognition and function.
Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, says, “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
Leqembi’s recommended use is for patients like those in the trial, who are living with mild cognitive impairment or a mild dementia stage. The monoclonal antibody is administered intravenously and targets amyloid by working with the body’s immune system.
Possible side effects may include brain swelling, confusion, dizziness, vision changes, headache, and infusion-related reactions like flu-like symptoms and changes in blood pressure. There have also been at least three deaths possibly linked to the medication after patients experienced brain swelling or bleeding.
Eisai’s U.S. chairman and CEO Ivan Cheung told NBC News that the drug is expected to cost $25,000 each year for one patient.Whizzco