A drug that can slow the decline in patients in the early stages of Alzheimer’s has been approved in the United States.
Lecanemab, sold under the name Leqembi, offers hope to patients yet to find an effective treatment. Leqembi is given every two weeks and was approved by the US Food and Drug Administration yesterday. It was allowed under a process that allows drugs to be fast-tracked if they “fill an unmet medical need”.
Some experts say that the drug has side-effects, with some patients experiencing brain swelling or brain bleeding.
The manufacturer Eisai said data from its phase-three trial involving 1,795 patients showed that about 12.6 per cent of patients experienced brain swelling, compared with 1.7 per cent in the placebo group. About 17 per cent of patients who received the drug experienced brain bleeding, compared with 9 per cent in the placebo group.
The New England Journal of Medicine reported that at least three deaths were possibly linked to the medication.
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Last week a US congressional report found that the FDA’s approval of an Alzheimer’s drug called Aduhelm, which is also made by Eisai and another company called Biogen, was rife with irregularities.
This included meetings with drug company employees that were not properly documented.
Scrutiny of the new drug is likely to mean that most patients will not start receiving it for months as health insurers in the US decide if and how to cover it.
Some six million people in the country have Alzheimer’s, a disease which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.
Leqembi works by clearing a sticky brain protein called amyloid that is one hallmark of Alzheimer’s. It’s not clear what causes the disease.
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A string of other amyloid-targeting drugs have failed and many researchers now think combination treatments will be needed.
Treating a patient with Leqembi costs between $9,249 to $35,605 annually.
