FDA approves Alzheimer’s Disease drug Leqembi

SILVER SPRING, MD. - The U.S. Food and Drug Administration on Thursday gave full approval Japanese drugmaker Eisai pharmaceutical company’s drug Leqembi (lecanemab-irmb), which is used to treat adult patients with Alzheimer’s Disease.

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. The disease slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.

While the specific causes of Alzheimer s are not fully known, it is characterized by changes in the brain—including the formation of amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections.

The number of Americans living with Alzheimer’s is growing — and growing fast. More than 6 million Americans of all ages have Alzheimer’s

An estimated 6.7 million Americans age 65 and older are living with Alzheimer’s in 2023. Seventy-three percent are age 75 or older.

• About 1 in 9 people age 65 and older (10.7%) has Alzheimer’s.

• Almost two-thirds of Americans with Alzheimer’s are women.

• Older Black Americans are about twice as likely to have Alzheimer’s or other dementias as older Whites.

• Older Hispanics are about one and one-half times as likely to have Alzheimer’s or other dementias as older Whites.

As the size of the U.S. population age 65 and older continues to grow, so too will the number and proportion of Americans with Alzheimer’s or other dementias. By 2050, the number of people age 65 and older with Alzheimer’s may grow to a projected 12.7 million, barring the development of medical breakthroughs to prevent or cure Alzheimer’s disease.

With full FDA approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott said in an interview.

“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. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

The approval comes after an FDA committee of outside experts voted unanimously that Leqembi’s pivotal trial results verify the med’s clinical benefit, with members describing the trial data as “robust,” “meaningful,” “consistent” and “significant.”

The process of converting the drug to full FDA approval also means that the vast majority of Americans with Alzheimer’s who get their health coverage through Medicare will be able to get the IV dispensed Leqembi through the federal program.

The Associated Press noted that there were concerns that the cost of new plaque-targeting Alzheimer’s drugs like Leqembi could overwhelm the program’s finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks.

Medicare administrator, Chiquita Brooks-LaSure, has made clear the program will immediately begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements the Associated Press reported.

Medicare recipients getting Leqembi must be enrolled in a federal registry to track the drug’s real-world safety and effectiveness. The information will help advance “knowledge of how these drugs can potentially help people,” Medicare officials said.

BRODY LEVESQUE