On Thursday, the U.S. Food and Drug Administration officially approved the Alzheimer’s medication lecanemab, which is sold under the brand name Leqembi.
“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 the acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, Teresa Buracchio.
Leqembi, created by Eisai and Biogen, is a pioneering medication that targets the fundamental biology of Alzheimer’s disease. It is the first drug to exhibit the ability to slow the advancement of the disease, including cognitive decline and memory loss.
“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,” Biogen president and CEO Christopher A. Viehbacher said in a statement.
He said the company will be “working alongside Eisai with the goal of making [Leqembi] accessible to eligible patients as soon as possible.”
Based on a single mid-stage study of 800 individuals with early-stage Alzheimer’s who were still capable of living independently or with little help, the FDA gave its initial approval for the drug in January.
Later, Eisai released the findings of a larger, 1,800-patient study, which the FDA had evaluated as part of the complete approval procedure.
The larger study monitored patients’ cognitive functions using an 18-point scale and showed a minimal difference of less than half a point after 18 months. This has sparked a debate on whether this small improvement can be considered meaningful.
In the most recent news release, it was announced that the decision reached by the committee was unanimous, with all members voting in agreement that the study results confirmed the drug’s efficacy.
Buracchio noted that “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” said Dr. Joy Snider, a neurologist at Washington University in St. Louis. “That might mean someone could have an extra six months to a year of being able to drive.”
Leqembi has certain downsides, as noted by Snider. These include the need for bi-monthly infusions and potential side effects like brain swelling. The Alzheimer’s Association has also reported infusion-related reactions and headaches as additional side effects.
The drug is estimated to cost around $26,500 for a normal year of treatment, which makes it difficult for many people to afford it.
Chiquita Brooks-Lasure, the leader of the Centers for Medicare and Medicaid Services, made a commitment on Thursday to “cover this medication broadly while continuing to gather data that will help us understand how the drug works” — a decision that will make it more affordable for many. Brooks-Lasure called the FDA’s approval “welcome news for the millions of people in this country and their families who are affected by this debilitating disease.”
Following the initial approval, the FDA called the drug “an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.”
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, former director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “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.”
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