British regulator approves new Alzheimer's drug

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The British Medicines Agency gave the green light on Thursday to a new Alzheimer's drug that has been proven to slow the progression of the disease, making it the first approved treatment of its kind in the UK.

Lecanemab, which is intended to slow cognitive decline in people with this neurological disease, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

However, the drug, developed by the Japanese pharmaceutical company Eisai, will not be introduced by the state-run National Health Service (NHS) because the spending regulator there considers it too expensive.

The benefits of lecanemab are “simply too small to justify the significant cost to the NHS,” said the National Institute for Health and Care Excellence (NICE).

Lecanemab was approved in the US last year, but was rejected by the European Medicines Agency (EMA) at the end of July.

The EMA said the drug's effect was “small” and that the “benefits of treatment were not sufficient to outweigh the risks associated with the medicine.”

In the US, the drug costs about £20,000 ($26,000) per patient per year.

Nevertheless, lecanemab is being praised by Alzheimer's researchers and charities as the first approved treatment that targets the early stages of the disease rather than just treating symptoms.

It works by using antibodies that bind to and eliminate the proteins that normally build up in the brains of people with Alzheimer's, the most common form of dementia.

In people in the early stages of the disease, treatment was shown to reduce cognitive decline by a quarter.

“Evidence from a clinical trial suggests that cognitive function in people taking lecanemab continues to deteriorate over time, but at a slower rate than in people taking placebo,” NICE said in its draft recommendation, adding that there was “no evidence of long-term effects.”

Hilary Evans-Newton, chief executive of the charity Alzheimer's Research UK, described the news of the approval as “bittersweet”.

“It is a remarkable achievement that science now provides approved treatments that can slow the devastating effects of Alzheimer's disease rather than just relieve symptoms,” Evans-Newton said.

However, the charity added that the treatment “will only be available to those who can afford the high costs in the private sector – which will be unaffordable for many”.

According to NICE, around five percent of people over 65 and 25 percent of people over 80 are thought to have mild dementia caused by Alzheimer's disease.

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