‘Game-changer’ self-injectable drug that can slow Alzheimer’s progression by up to eight years is approved in US – and could soon be available on NHS

A self-injectable drug that slows the progression of Alzheimer’s by up to eight years has been approved in the US and will soon be available on the NHS.

The ‘game-changing’ vaccine is given once a week and can be administered at home in just 15 seconds, saving users from having to go to hospital.

Previously, it was given via intravenous drip, which took an hour to infuse and placed a heavy burden on patients, medical staff and beds.

The drop version is available privately in the UK but drugs watchdog NICE has ruled that it should not be offered on the NHS because it does not offer value for money.

This was largely due to the resource-intensive delivery method, which, not including the cost of the drug, can run into hundreds of pounds at a time.

The U.S. Food and Drug Administration today approved the use of an injectable version of lecanemab to treat early Alzheimer’s disease, saying patients can go directly to the shot without needing to start an infusion.

It will be available for purchase in the US starting next month.

The development raises hopes that the drug will pass NICE’s affordability tests, paving the way for it to be made available on the NHS, charities said tonight.

The U.S. Food and Drug Administration today approved the injectable version of lecanemab for the treatment of early Alzheimer’s disease.

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: ‘An injectable version of lecanemab from the start of treatment would be a game changer in terms of convenience for people and affordability of administration for healthcare services.

‘The UK risks falling further behind as we continue to struggle over licensed treatments that are not currently available on the NHS.

‘The cost of IV infusions has been identified as one of the key barriers to cost-effectiveness.

‘Patients and families across the UK expect these advances to be delivered, and the government must deliver on its manifesto commitment to put Britain at the forefront of transforming dementia care.’

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator, is expected to comply with the FDA’s decision when considering Japanese drugmaker Eisai’s application.

A trial presented at the Alzheimer’s conference in December showed that lecanemab could delay the progression of the disease from mild cognitive impairment to moderate Alzheimer’s disease by 8.3 years in patients who had low levels of amyloid protein in the brain and started treatment at an early stage.

Mild cognitive impairment due to AD is the earliest symptomatic stage of Alzheimer’s disease and can present with mild symptoms such as forgetfulness, confusion, or feeling at a loss for words.

Announcing the FDA approval, Eisai said the weekly vaccine is expected to be as effective as intravenous treatment and have a similar safety profile, as well as placing less ‘burden’ on healthcare systems.

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said the injectable version of lecanemab would be a ‘game changer’ from the start of the treatment.

He stated that the new formulation was ‘highly preferred by patients’ and 97 percent were satisfied with it.

Users loved the speed, convenience, and less painful application, as well as the ability to travel away from home and not be close to a hospital.

Lecanemab represents a major step forward in research because it targets a known cause of the disease rather than just treating symptoms.

It binds to amyloid, a protein that accumulates in the brains of people living with Alzheimer’s disease.

The drugs are designed to bind to amyloid, helping to clear the buildup and slow cognitive decline.

Dr Richard Oakley, deputy director of research and innovation at the Alzheimer’s Society, said people living with dementia were ‘desperate’ for new treatments that give them more time before symptoms worsen.

But he warned: ‘The reality is that even if lecanemab were to become available on the NHS tomorrow, our healthcare system is not ready to deliver it.

‘A third of people with dementia in the UK go undiagnosed, and services are not equipped with the staff and tools needed to diagnose more people quickly and monitor people for new treatments.

‘We need to see urgent investment in preparing health systems to deliver new treatments, with clear national targets on early and accurate diagnosis to ensure the right people have access to the right treatments when they are most effective.’

The list price of subcutaneous therapy in the US is £288 per auto-injector, which equates to an annual cost of induction therapy per patient of £29,900.

The list price for induction IV therapy in the US is £19,800 per year for a patient weighing 70kg, excluding the cost of delivery of the drug.

Both treatments can be reduced to a less frequent ‘maintenance’ regimen after 18 months, resulting in lower annual costs.

NICE’s review committee met earlier this month to consider new evidence following an appeal of its decision to reject the use of intravenous lecanemab and a similar drug on the NHS. It is expected to present its findings next month.

A Department of Health and Social Care spokesman said the government had delivered the ‘biggest expansion of NHS diagnoses in a generation’.

They added: ‘We will continue to invest in the latest technology and expand the workforce so patients can get the care they need quickly.’