A new Alzheimer’s medication received a first-of-its-kind approval from the U.S. Food and Drug Administration this week.
Here’s what you need to know about Leqembi, the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of the debilitating condition.
How does Leqembi work?
According to the FDA, the “drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease,” and study results published in The New England Journal of Medicine showed that the drug binds with amyloid-beta soluble protofibrils to do this.
Deposits of beta-amyloid peptide build up in the spaces between nerve cells to form plaques found in Alzheimer’s patients, according to the Alzheimer’s Association. These plaques, are one of the hallmark signs of Alzheimer’s. Other symptoms of the disease include memory loss, confusion and mood changes, as well as disorientation, difficulty speaking, talking and walking.
So far, progression of Alzheimer’s disease is irreversible and it affects more than 6.5 million Americans. While Leqembi is not a cure for the disease, it is the “first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease,” according to a press release from Biogen.
“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,” said Joanne Pike, president and CEO of the Alzheimer’s Association. “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.”
How did the FDA decide to approve Leqembi?
In January, the FDA first approved Leqembi under the Accelerated Approval pathway, which “allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug’s effect on a surrogate endpoint.”
As part of the approval process, the FDA required its manufacturers to conduct a clinical trial, to verify the drug’s clinical benefit. Last month, the Peripheral and Central Nervous System Drugs Advisory Committee voted that the results of the study verified the clinical benefit of Leqembi for the indicated use.
Per the FDA description, this trial was a “multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease,” and that “Leqembi demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint.”
“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,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research Thursday. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Does Leqembi have side effects?
Yes. According to the FDA, the most common side effects were: headache, infusion-related reactions and amyloid-related imaging abnormalities (ARIA).
“ARIA most commonly presents as temporary swelling in areas of the brain seen on imaging studies that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain,” explained the administration. “Although ARIA is often not associated with any symptoms, symptoms can occur and include headache, confusion, dizziness, vision changes and nausea. ARIA can also infrequently present with serious and life-threatening brain edema that can be associated with seizures and other severe neurological symptoms.”
Aduhelm, another Alzheimer’s drug approved by the FDA, is also associated with ARIA risk.
Additionally, the use of anticoagulant medication was associated with an increased number of intracerebral hemorrhages in patients taking Leqembi compared to those taking a placebo.
When will Leqembi be available?
With the FDA approval of Leqembi, the Centers for Medicare & Medicaid Services announced broader coverage of the medication. This coverage is now available through a registry where healthcare professionals can submit patient data, said its manufacturers.
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