BRITAIN'S medicines regulator granted approval on Thursday (22) for a new Alzheimer’s drug, marking the country's first licensed treatment aimed at slowing the progression of the disease.
The drug, lecanemab, which targets cognitive decline in individuals with Alzheimer's, received approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
Despite this approval, the drug will not be available through the National Health Service (NHS) as the National Institute for Health and Care Excellence (NICE) has deemed it too costly for widespread use.
NICE stated that the benefits of lecanemab are not substantial enough to justify the significant expense, leading to its exclusion from NHS provision.
The drug has been developed by Japanese pharmaceutical company Eisai.
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 that the impact of the drug was "small" and the "benefits of treatment are not large enough to outweigh the risks" associated with the medicine.
In the US, the drug costs around £20,000 ($26,000) per patient, per year.
However, lecanemab has been hailed by Alzheimer's researchers and charities for being the first approved treatment which tackles the early stages of the disease, rather than managing the symptoms.
It works by using antibodies which bind to and clear the proteins that normally build up in the brains of people with Alzheimer's, the most common type of dementia.
The treatment has been shown to decrease cognitive decline by a quarter in people in the early stages of the disease.
"Evidence from a clinical trial suggests that people having lecanemab continue to have worsening cognitive function over time, but at a slower rate than people on placebo", NICE said in its draft recommendations, adding that there was a "lack of evidence on the long-term effects".
The news of the approval was described as "bittersweet" by Hilary Evans-Newton, chief executive at charity Alzheimer's Research UK.
"It's a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer's, rather than just alleviating its symptoms," Evans-Newton said.
However, the charity added the treatment would "only be available to those who can afford its steep price tag in the private sector – which will be prohibitive for many".
Mild dementia caused by Alzheimer's is thought to be present in around five percent of people over 65 and 25 percent over the age of 80, according to NICE. (AFP)
Vikram Doraiswami
Andrew Quintman
Lord Jitesh Gadhia