New Alzheimer’s Drug Leqembi is Granted Full FDA Approval

Updated: 7/6/2023

The US Food and Drug Administration (FDA) has granted full (traditional) approval to the Alzheimer’s drug, Leqembi. This is the first drug that has been proven in clinical trials to slow the progression of this neurodegenerative disease in its early stage.

The approval is expected to trigger coverage by the Centers for Medicare and Medicaid Services. This will expand access to the drug for an estimated one million people diagnosed with early-stage disease.

“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,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in news release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Leqembi is manufactured by drugmakers Eisai and Biogen. Biogen president and CEO, Christopher A. Viehbacher said in a statement: “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.”

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The U.S. Food and Drug Administration (FDA)  has just granted accelerated approval for lecanemab, a drug that trials show may slow the progression of cognitive decline in the early stages of Alzheimer’s disease. 

Marketed under the name Lequembi, the medication is delivered by intravenous infusion every few weeks. Though it also carries the risk of swelling and bleeding in the brain, experts have said it shows promise in a category short on effective treatments. Whether or not cognitive improvements from the drug’s use are meaningful to patients remains unclear, experts caution.

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“Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease,” the agency said in a press release. “These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.”

Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Results from a recent trial supported this decision, the FDA said, based on imaging studies that observed a reduction of amyloid beta plaque in the brain, a known marker for Alzheimer’s, after the drug was administered. 

Easai, a Japanese pharmaceutical maker, led the development of the drug. It will partner with Biogen on marketing and distribution and split the profits evenly, a New York Times report said. 

Both Biogen and the FDA recently faced strong criticism for the accelerated approval of another Alzheimer’s drug, Aduhelm. A congressional report excoriated both the FDA and Biogen for the controversial drug’s approval process.

“The FDA granted accelerated approval for Aduhelm on the basis that the drug reduces amyloid beta plaque in the brain,” the congressional report said. “The FDA’s action came despite the fact that Biogen canceled clinical trials for Aduhelm in March 2019 due to an independent report indicating the drug was unlikely to effectively slow cognitive and functional impairment and that further clinical study would be futile.”

Easai said it will announce pricing for Lequembi soon. They also cautioned doctors to prescribe only for patients who are in the early stages of Alzheimer’s and to run tests to determine whether or not there is a build up of protein amyloid in the brain that Lequembi is designed to target.