The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in 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 harshly criticized in a congressional report for its green-lighting of another Alzheimer’s drug, Aduhelm.
And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding.
Both drugs were approved through an accelerated process that allows the FDA to fast-track 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 of the United States, “represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease,” the FDA said in a statement.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it 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, instead of only treating the symptoms of the disease.”
Slowed cognitive decline
Approximately 6.5 million Americans suffer from Alzheimer’s, which is characterized by memory loss and declining mental acuity.
Preliminary data from a trial of Leqembi was released in September and found it slowed cognitive decline in Alzheimer’s patients by 27 percent.
The phase three trial involved nearly 1,800 people, divided between those given the drug and given a placebo, and ran over 18 months.
The complete trial data, published in the New England Journal of Medicine, raised concern about the incidence of “adverse effects,” including brain bleeds and swelling.
Source: FDA, Inquirer