us congressional report criticized fda approval process biogen drug treat alzheimer afp

The United States approves a new drug to treat Alzheimer’s

The U.S. Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in the mild and early stages of Alzheimer’s disease.

The FDA approval of the drug, Leqembi, also known as lecanemab, comes days after the regulatory agency was sharply criticized in a congressional report for giving the green light to another Alzheimer’s drug, the l ‘Aduhelm.

And it was granted despite the study results showing that treatment with monoclonal antibodies carries risks of brain swelling and bleeding.

Both drugs were approved through a fast-track process that allows the FDA to expedite drug approval for serious conditions where there is an unmet medical need.

Leqembi and Aduhelm, which were jointly developed by Japan’s Eisai and US Biogen, “represent a major advance in the ongoing fight to effectively treat Alzheimer’s disease,” the FDA said in a statement.

“Alzheimer’s disease immeasurably impairs the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn of the FDA’s Center for Drug Evaluation and Research in a statement.

Leqembi, Dunn said, is “the latest therapy to target and influence the underlying disease process of Alzheimer’s, instead of just treating the symptoms of the disease.”

About 6.5 million Americans suffer from Alzheimer’s, which is characterized by memory loss and decreased mental acuity.

Preliminary data from a trial with Leqembi was released in September and found that it slowed cognitive decline in Alzheimer’s patients by 27%.

The phase three study involved nearly 1,800 people, split between those given the drug and those given a placebo, and lasted 18 months.

The full data from the study, published in the New England Journal of Medicine, raised concerns about the incidence of “adverse effects,” including brain hemorrhages and swelling.

The results showed that 17.3% of patients given the drug had bleeding in the brain, compared with 9% of those given a placebo.

And 12.6% of those who took the drug experienced brain swelling, compared with just 1.7% of those in the placebo group.

Deaths were reported at approximately the same rate in both arms of the drug trial.

$26,500 annually

In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up in tangles and plaques, together known as clumps, which cause brain cells to die and lead to brain shrinkage.

Leqembi, which is given intravenously once every two weeks, works by targeting amyloid.

In the study, patients treated with Leqembi had a statistically significant reduction in brain amyloid plaque compared to the placebo arm, which had no reduction in beta-amyloid plaque.

Biogen and Eisai had previously brought Aduhelm to market, but there was significant controversy over how it worked, and its approval in 2021 led to three high-level resignations from the FDA.

A US congressional investigation said the fast-track approval process for Aduhelm, the first drug approved in decades to treat Alzheimer’s, was “riddled with irregularities” and criticized both the agency and Biogen.

Cambridge, Massachusetts-based Biogen has set an “unjustifiably high price” for Aduhelm of $56,000 a year, the congressional report said.

Eisai said Leqembi would initially be priced at $26,500 a year and estimated 100,000 Americans could receive the drug within three years from now.

Joanne Pike, president and CEO of the Alzheimer’s Association, welcomed Leqembi’s approval but expressed concern that its high cost could put it out of reach for most Americans, particularly if it’s not covered by Medicare. the government’s health insurance program for the elderly.

“People living with this deadly disease today don’t have time to wait for a drug or miracle cure,” Pike said in a statement.