FDA approves new Alzheimer’s drug designed to slow cognitive decline: ScienceAlert

The US Food and Drug Administration (FDA) on Friday approved a long-awaited 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 just days after the regulatory agency was heavily criticized in a congressional report for the green light for another Alzheimer’s drug, Aduhelm.

And it was given despite test results showing that the monoclonal antibody treatment carries a risk of brain swelling and bleeding.

Both drugs were approved through an accelerated process that allows the FDA to speed up the approval of drugs for serious conditions where there is an unmet medical need.

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

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

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

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

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

The phase three study involved almost 1,800 people, divided between those who received the drug and those who received a placebo, and lasted for 18 months.

The full trial data, published in New England Journal of Medicineraised concerns about the occurrence of “adverse effects” including brain hemorrhages and swelling.

The results showed that 17.3 per cent of the patients who received the drug experienced brain haemorrhages, compared to nine per cent of those who received the placebo.

And 12.6 percent of those taking the drug experienced brain swelling, compared to just 1.7 percent of those in the placebo group.

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

26,500 dollars a year

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

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

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

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

A US congressional investigation said the accelerated 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.

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

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

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

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

?© Agence France-Presse

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