US health officials have approved a drug that has been shown to slow the early stages of Alzheimer’s disease.
The drug, Leqembi, can make a modest impact on the progress of the degenerative brain disease, but it also comes with potential safety risks that doctors and patients will have to carefully weigh.
The treatment is the first to convincingly slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease’s underlying biology.
The US Food and Drug Administration (FDA) approved it specifically for patients with mild or early cases of dementia.
Today, we approved a new medication for the treatment of Alzheimer’s disease, the second of a new category of medications approved for Alzheimer's that target the fundamental pathophysiology of the disease. https://t.co/ZXJCUuTYPk pic.twitter.com/TV36k6CO6K
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Leqembi, from Japan’s Eisai and its US partner Biogen, is a rare success in a field accustomed to failed experimental treatments for the incurable condition.
The delay in cognitive decline brought about by the drug likely amounts to just several months, but some experts say it could still meaningfully improve people’s lives.
Dr Joy Snider, a neurologist at Washington University in St Louis, said: “This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease.
“That might mean someone could have an extra six months to a year of being able to drive.”
Dr Snider stressed that the medicine comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling and bleeding.
Approval came via the FDA’s accelerated pathway, which allows drugs to launch based on early results, before they are confirmed to benefit patients.
The agency’s use of that shortcut has come under increasing scrutiny from government watchdogs and congressional investigators.
The US Food and Drug Administration and Biogen, manufacturer of the drug for Alzheimer’s disease aducanumab, have been heavily criticised by two government committees for the atypical way they collaborated to grant accelerated approval for ithttps://t.co/Dk0S7DfSZJ
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Last week, a congressional report found that FDA’s approval of a similar Alzheimer’s drug called Aduhelm – also from Biogen and Eisai – was “rife with irregularities”, including a number of meetings with drug company staff that went undocumented.
Scrutiny of the new drug, known chemically as lecanemab, will likely mean most patients will not start receiving it for months, as insurers decide whether to cover it, and for whom.
The drug will cost 26,500 US dollars (£22,150) for a typical year’s worth of treatment. Eisai said that price reflects the drug’s benefit in terms of improved quality of life, reduced burdens for caregivers and other factors.
The company pegged its overall value at 37,000 dollars (£30,900) per year, but said it priced the drug lower to reduce costs for patients and insurers. An independent group that assesses drug value recently said the drug would have to be priced below 20,600 dollars (£17,200) to be cost-effective.
Some six million people in the US and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.
The FDA’s approval was based on one mid-stage study in 850 people with early symptoms of Alzheimer’s who also tested positive for a type of brain plaque that is a hallmark of the disease.
