FDA Approves New Alzheimer’s Drug To Slow Disease
The Food and Drug Administration just fully approved the world’s first Alzheimer’s drug that’s meant to slow the progression of the disease.
The groundbreaking drug Leqembi is officially the first drug designed to slow the progression of Alzheimer’s that’s been granted full regulatory approval. Until now, Alzheimer’s drugs have acted to target the symptoms of the disease and not the disease itself.
According to NBC News, Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky, said: “I don’t think we can understate the significance of this moment.”
According to the Alzheimer’s Association, Alzheimer’s disease effects around 6.7 million adults ages 65 and older in the United States. The disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills. It’s devastating to millions of people and their loved ones.
The FDA notes that Leqembi works by reducing amyloid plaques that form in the brain, “a defining pathophysiological feature of the disease.”
While Leqembi was approved back in January under the Accelerated Approval pathway, it passed standard approval on July 06, 2023.
In an Alzheimer’s Association press release, Joanne Pike, DrPH, Alzheimer’s Association president and CEO, said: “This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love. While we continue efforts to discover new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment is right for them.”
We are pleased to announce that the FDA has granted traditional approval of our treatment for early #AlzheimersDisease. Thank you to the many patients, families and researchers who have made this significant milestone possible.
— Eisai US (@EisaiUS) July 7, 2023
The press release went on to explain that the drug’s clinical trials “clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer’s.”
Leqembi was found to delay cognitive decline in people with Alzheimer’s disease by 5.3 months compared to placebo after 18 months of treatment.
“Further delays in progression are anticipated with extended time under treatment,” the Alzheimer’s Association wrote.
Leqembi is administered twice monthly through intravenous infusion. Medicare has also announced that they will cover the drug.
In a statement to the FDA, Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said, “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
The FDA notes that Leqembi “should be initiated in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease, the population in which treatment was studied in clinical trials.”
