US becomes first country in the world to approve gamechanger Alzheimer’s drug lecanemab

US health officials today approved the first Alzheimer’s drug proven to slow the condition – in what could be a breakthrough for millions of patients.

Lecanemab, which will be sold under the brand name Leqembi, instantly becomes the most effective treatment on the market after being given accelerated approval by the Food and Drug Administration (FDA) Friday.

The drug – administered every two week as an intravenous infusion – was shown to slow the progression of cognitive decline by more than a quarter in patients with early-stage Alzheimer’s compared to a control group.

Experts told DailyMail.com the approval was a ‘landmark’ moment, but expressed concerns about how many people will access the drug, which will cost around $26,500 a year.

Eisai, a Japanese pharmaceutical giant that led the development and testing of the drug, has formed a commercial partnership with American firm Biogen and the two will split the profits equally.

Lecanemab works by clearing plaque that forms in the brain of people with dementia.

In clinical trials, those who received the drug saw their mental condition deteriorate 27 percent less than the control group. 

Some experts have cast doubts over the drug’s effectiveness, though, and safety concerns were raised after three patients died in clinical trials. 

Last year, Biogen’s other controversial Alzheimer’s drug, Aduhelm, was widely criticized after receiving the FDA greenlight.

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

‘This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.’ 

Development and research on the drug was carried out by the Tokyo, Japan-based firm Eisai. It partnered with the Biogen, from Cambridge, Massachusetts, for the marketing of it.

Upon approval, the FDA has recommended the drug to be used in patients that are in the early and middle stages on Alzheimer’s. This includes at least 1.5million of the 6.5million Americans diagnosed with the condition.

Phase III clinical trials included 1,795 patients will early Alzheimer’s. Half of participants were given 10mg/kg of the drug every two weeks.  The other group was instead given a placebo.

Researchers measured the memory, judgement and problem solving ability of participants before the trial began and again at 18 months.

They found that those who were on the drug saw their cognitive state deteriorate at a pace 27 percent slower than the placebo. 

‘The trial data has shown that lecanemab has a small but measurable impact in slowing the progression of Alzheimer’s,’ Hillary Evans, chef executive of Alzheimer’s Research UK, said in a statement.

‘In practice, lecanemab’s benefits are likely to be measured in extra months rather than years. Yet as anyone affected by Alzheimer’s knows, this time can be precious.’

Regulators in the UK are expected to clear the drug for use this year. 

It did come with some dangers, though. One-in-eight participants who used lecanemab experienced brain swelling, compared to one-in-fifty members of the control group.

These cases were not symptomatic, though, according to the pair of firm’s behind the drug.

Micro-hemorrhages, or small spurts of bleeding on the brain, were twice as common in the lecanemab group than the placebo group – with 17 percent suffering the issue.

The drug’s label will also include cautions against using blood thinners while using lecanemab – a known risk for drugs that combat amyloid beta plaques on the brain.

Two of three patients who died in clinical trials after experiencing brain bleeding and swelling were also being treated with blood thinners.

Deaths occurred at the end of the trial, at a point where they knew they were being treated with the drug and not a placebo. 

The promising trials have many experts excited, though. There are currently no effective treatments for Alzheimer’s itself – and doctors will usually just help patients manage symptoms as they continue to decline.

Institute for Clinical and Economic Review, which assesses the value of medicine, said the value of the drug is between $8,500 to $20,600 per year. This makes the $26,500 price tag set by Eisai an oversell.

Last year, the FDA approved Aduhelm for treatment of Alzheimer’s. The controversial approval was widely criticized by experts after dubious results in trials. 

That drug targeted amyloid plaques on the brain that had already formed. It is believed that the formation of these deposits on the brain are responsible for cognitive decline.

Lecanemab instead targets the proteins that form these plaque deposit before they clump together, making experts hopeful it will be more effective than its predecessor.

The Aduhelm debacle has left a sour taste in the mouth of some Americans, though.

A congressional investigation revealed last week that the approval process for the drug was ‘rife with irregularities’.

‘The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,’ the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.