The US has approved a NEW drug that can slow down the progression of Alzheimer’s.
Leqembi (Lecanemab), a commercial name for Lecanemab will be made available to patients who have mild dementia or other symptoms in the early stages.
This is the first medication that has been shown to slow down cognitive decline.
In January, the Food and Drug Administration gave conditional approval to Japanese drugmaker Eisai based on preliminary results that suggested Leqembi cleared a sticky plaque in the brain linked to the illness.
After the 1,800 patient study that found the drug slows memory and thinking by 27% over 18 months it is now green-lighted – increasing pressure on Britain.
Hilary Evans is the chief executive of Alzheimer’s Research UK. She said, “This welcome announcement from the US signals an important step in a world that Alzheimer’s can be treated, but also serves as a warning.”
The data collected from an extensive study of 1,800 patients was carefully reviewed to reach today’s decision.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is leading a similar process.
We’ve written the MHRA to urge them to finish this review urgently, without compromising quality, so that people with Alzheimer’s disease in the UK don’t remain in limbo.
“We believe a quick regulatory decision on lecanemab would further strengthen the UK’s international reputation as an expert in dementia. It would also attract more commercial investment into UK clinical trials and benefit those of us who may develop dementia or who care for someone with it in the future.
The news of today highlights the need to get the NHS prepared for new medicines such as lecanemab.
The FDA’s neurology director Teresa Buracchio stated that Leqembi is “safe and effective”. However, the packaging will include the most severe warnings as it may cause brain swelling or bleeding.
Leqembi is available for around $26,500 (PS20,000) per year, although insurers may negotiate this price.
Every two weeks, it is administered as an injection.
Eisai informed investors that approximately 100,000 Americans may be eligible for the treatment by 2026.
A marketing authorisation application was submitted in May in the UK. A decision is expected before the end of this year.
Prof David Curtis (honorary professor, UCL Genetics Institute) said, “This is truly remarkable news.
There are serious concerns about side effects, and there is a question about the balance of clinical benefits and overall costs.
This decision, however, identifies Alzheimer’s as a disease that can be potentially treated or prevented rather than just endured.
According to the Alzheimer’s Association, Alzheimer’s accounts for 60-80 percent of all dementia.