Patients have been warned not to turn to private companies for a new “miracle” Alzheimer’s drug after reports emerged that two people in the US died from suspected side effects over the past year.
The drug, lecanemab, has been shown to slow the deterioration of this degenerative brain disease by about six months.
Last week, the NHS spending watchdog rejected the infusion drug because the benefits were “too small to justify the cost”.
The National Institute for Health and Social Care Excellence (NICE) also added that there were concerns that patients would need to be monitored for “serious side effects”.
Last week, the NHS spending watchdog rejected the infusion drug as the benefits were “too small to justify the cost” (file photo)
Experts say about 3,000 patients have started taking the drug since it was approved by U.S. health officials in July 2023 (file photo)
About one in ten trial participants experienced swelling in the brain and one in six had small brain bleeds, which in rare cases led to life-threatening symptoms. Three patients died in the trial with 1,800 participants due to suspected side effects.
However, lecanemab, which is estimated to cost £20,000 a year, will now be available on the private market in the UK. Experts predict that thousands of desperate patients will turn to private providers for lecanemab, but warn that they could be putting their health at risk.
Earlier this month, it was reported at the Alzheimer’s Association International Conference in Philadelphia that two patients had died from suspected side effects after taking lecanemab in the United States.
Experts say about 3,000 patients have started taking the drug since it was approved by U.S. health officials in July 2023.
Dr. Lawrence Honig, a neurologist at Columbia University in New York, confirmed one death. The science news website Alzforum reported a second death. Neither patient has been identified, but, according to Dr. Honig, one of them carried a gene (called APOE4) that research shows increases the risk of brain hemorrhage. About 15 percent of Alzheimer’s patients carry this gene.
Lecanemab, which is estimated to cost £20,000 a year, will now be available on the private market in the UK (file photo)
Lecanemab and donanemab work by attacking a toxic protein in the brain called amyloid, which is linked to dementia symptoms.
“Anyone who can afford to buy this drug privately should carefully consider the benefits and risks and decide whether lecanemab is worth taking,” says Robert Howard, professor of old-age psychiatry at the Institute of Mental Health at University College London.
“People think it will buy them more time, but the data shows only a marginal benefit. In the meantime, the risks are very real.”
There are one million people in the UK suffering from Alzheimer’s and there are currently no NHS treatments that can stop the disease. Lecanemab – and a similar drug called donanemab – are the first treatments that have been shown in clinical trials to combat the loss of brain function caused by Alzheimer’s.
The drugs are administered every two weeks as an infusion. Lecanemab and donanemab work by attacking a toxic protein in the brain called amyloid, which is linked to the symptoms of dementia.
Last year, when the results of trials for both drugs were announced, experts said the findings marked the “beginning of the end” of Alzheimer’s. However, since then, the treatments have been plagued by controversy. The Ministry of Health was the first to report the death of Genevieve Lane, a 79-year-old lecanemab trial participant from Florida, who suffered a fatal seizure in 2022, just a week after her third dose. An autopsy concluded that lecanemab was likely to have triggered the rupture of a blood vessel in Genevieve’s brain that led to her death. Two other deaths in the trial were linked to side effects. Earlier this year, this newspaper also revealed that senior NHS officials had raised concerns that the treatments could cost the taxpayer £1bn a year to roll out, as well as putting the lives of Alzheimer’s patients at risk.
Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody drug used for the treatment of Alzheimer’s disease.
There are one million Alzheimer’s sufferers in the UK and there are currently no NHS treatments that can stop the disease.
The drugs were only effective when given at the earliest stages of the disease, according to a report by the National Health Service. It also suggested that monitoring patients for possible side effects could require a significant amount of resources.
Last week, when NICE spoke out against the introduction of lecanemab on the NHS, it referred to these concerns. Dr Samantha Roberts, head of NICE, said: “It is an intensive treatment given to patients, which involves a visit to hospital every two weeks with specialist staff monitoring them for signs of serious side-effects, not to mention the cost of buying the drug.”
A spokesman for Eisai, the company that makes lecanemab, said: ‘The second death described in the media was acknowledged as a rumour by the media outlet that first reported it.
“Eisai is not in a position to respond to rumours. Eisai continues to comply with its obligations to monitor and report adverse events in accordance with global regulatory requirements.”
