US Drug Enforcement Administration Approves New Alzheimer’s Drug

On Thursday, the US Drug Enforcement Administration fully approved a new Alzheimer’s drug to be widely available through public health insurance for older adults.

Little Improvement in Cognitive Decline

Lekambi, which was jointly developed by Eisai of Japan and Biogen of the United States, has shown little improvement in cognitive decline in patients in the early stages of the disease in clinical trials.

Concerns About Side Effects

But the study also raised concerns about side effects, including cerebral hemorrhage and swelling.

Fast Track Approval and Medicare Coverage

Lekambi initially received “fast track approval” from the Food and Drug Administration in January, meaning he was not widely covered by the state’s Medicare program for people aged 65 and over.

Medicare Will Cover the Treatment

Thursday’s decision, after further review of the drug, means Medicare will now pay for most of the treatment originally listed by manufacturers at $26,500 a year.

Positive Statements from FDA and Medicare Officials

“This confirmatory study demonstrates that this is a safe and effective treatment for patients with Alzheimer’s disease,” Teresa Buraccio, a senior FDA official, said in a statement.

“This is good news for the millions of people in this country and their families affected by this debilitating disease,” added Chiquita Brooks Lashore, director of the agency that manages the Medicare program.

Description and Benefits of Lekambi

Lekambi, also known as lekanemab, is described as a treatment with antibodies injected into the brain every two weeks that work by reducing beta-amyloid, a protein that accumulates in plaque and causes brain cell death and shrinkage.

“This treatment, while not a cure, may give people in the early stages of Alzheimer’s disease more time to maintain their independence and do what they love,” said Joan Pike, president and CEO of the Alzheimer’s Association.

Previous Approvals and Controversy

Leqembi was the second Alzheimer’s drug developed by Eisai and Biogen to receive approval. The first one, Aduhelm, was approved in 2021, but this decision has been highly controversial as data on its effectiveness has been inconsistent.

Potential Future Drug

And in May, American drug maker Eli Lilly announced that its drug donanemab significantly slows Alzheimer’s-related cognitive decline and will soon seek approval from global regulators.

Source: Science Alert