First Alzheimer's drug to slow disease gets full FDA approval
The U.S. Food and Drug Administration on Thursday granted traditional approval to the Alzheimer's drug lecanemab, known by the brand name Leqembi, after an accelerated approval was issued earlier this year.
"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 a news release.
Leqembi, from drugmakers Eisai and Biogen, is the first medication that's been shown to slow the progression of Alzheimer's disease, including declines in memory and thinking, by targeting the disease's underlying biology.
"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."
The FDA's initial approval in January was based on one mid-stage study in 800 people with early signs of Alzheimer's who were still able to live independently or with minimal assistance. Eisai later published the results of a larger 1,800-patient study that the FDA assessed as part of the full approval process.
The larger study tracked patients' results on an 18-point scale measuring memory and other cognitive functions. Results showed a difference of less than half a point after 18 months, sparking debate over whether this qualifies as a meaningful improvement.
According to the latest news release, the decision was unanimous, with all committee members voting that the study results verified the drug's benefit. Buracchio noted in her statement: "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," Dr. Joy Snider, a neurologist at Washington University in St. Louis, told The Associated Press in January. "That might mean someone could have an extra six months to a year of being able to drive."
Snider said that Leqembi (pronounced "leh-KEM-bee") also comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling. Other reported side effects are infusion-related reactions and headaches, according to the Alzheimer's Association.
Access is another issue, with the drug expected to be priced at about $26,500 for a typical year's worth of treatment, without insurance.
On Thursday, the head of the Centers for Medicare and Medicaid Services, Chiquita Brooks-Lasure, pledged 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."
Her office had previously said it expected to extend coverage once full FDA approval was granted.
The FDA defines Alzheimer's disease as "an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks."
In a news release from the initial approval, the FDA called the medication "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," Dr. Billy Dunn, former director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in the release. "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."
The decision on Leqembi follows controversy over the FDA's handling of a previous Alzheimer's drug, Aduhelm, which was also developed by Biogen and Eisai. Aduhelm won approval in 2021 despite warnings from independent medical advisers that it had not been shown to be effective and carried significant risks. The FDA later updated labeling to significantly limit the drug's use.
Alex Tin contributed reporting. The Associated Press also contributed to this report.