FDA approves Alzheimer’s drug Leqembi

In an announcement Thursday, the U.S. Food and Drug Administration announced that Lequembi, an Alzheimer’s drug, has been approved.

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The FDA said in a news release Leqembi is the first “amyloid beta-directed antibody” to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works to reduce plaques of amyloid that form in the brain.

Leqembi is the first Alzheimer’s antibody treatment that has been fully approved by the FDA, CNBC reported.

The FDA endorsed the drug for patients who have mild dementia and other symptoms that are caused by the early stages of Alzheimer’s, The Associated Press reported. It is the first medicine shown to slow Alzheimer’s cognitive decline.

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

The New York Times reported that the drug cannot repair any cognitive damage but it can help to reverse the course of the disease or even prevent it from getting worse.

It is also the first drug of its kind that is expected to receive broad coverage through Medicare, according to CNBC. Medicare coverage of Leqembi is a huge step to help older Americans with early stages of the disease be able to pay for treatment.

Eisai, a Japanese drugmaker, received “conditional approval” for the drug from the FDA in January due to early results that suggested that the drug had worked by “clearing a sticky brain plaque linked to the disease, according to the AP.

Alzheimer’s disease affects 6.5 million Americans. According to the FDA, it is an irreversible, progressive brain disorder.

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,” according to the FDA.