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US approves breakthrough drug Leqembi to treat Alzheimer's

08 January 2023 01:00

The US Food and Drug Administration [FDA] has 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 on January 6 just days after the regulatory agency was harshly criticised in a congressional report for its green-lighting of another Alzheimer's drug, Aduhelm.

It was granted despite the fact that trial results showed the monoclonal antibody treatment carries risks of brain swelling and bleeding, TRT World reports.

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."

Approximately 6.5 million Americans suffer from Alzheimer's, which is characterised by memory loss and declining mental acuity.

Caliber.Az
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