The United Kingdom approves Leqembi for Alzheimer's treatment use
Alzheimer's, an incurable illness at present, is being tackled by researchers to at least delay its initiation. The drug Leqembi has shown potential in this aspect, recently obtaining approval from the UK's drug regulatory body, following similar approval in the US. However, the UK's National Health Service (NHS) will not subsidize it due to its high cost.
The UK's drug regulatory body, the MHRA, has given the thumbs up to the Alzheimer's drug Leqembi. It's the first medication against Alzheimer's to receive approval in the UK and has been demonstrated to slow down the development of the disease, according to the agency.
However, Leqembi will not be accessible through the NHS due to its high price, as deemed by the relevant financial authority. The National Institute for Health and Care Excellence (NICE) stated that the benefits of Lecanemab, the active ingredient in Leqembi, are not enough to cover the substantial costs to the NHS.
Leqembi is intended for patients in the early stages of Alzheimer's. It is administered intravenously every two weeks and targets a protein called beta-amyloid, which forms deposits in the brains of Alzheimer's patients. While it cannot cure the disease, it seems to slow down its progression.
Leqembi was approved in the US last year, with an annual cost of around $26,000 (€23,000) per patient. Alzheimer's researchers and charities emphasize that Lecanemab is the first recognized drug to combat the disease in its early stages, rather than just managing its symptoms.
Risk of brain hemorrhages
The European Medicines Agency (EMA) turned down Leqembi's approval in late July, citing the risk of severe side effects, including brain hemorrhages, outweighing its benefits in tackling cognitive decline.
The UK regulator noted that the risk of brain hemorrhages is especially high in individuals with a specific genetic profile, making up 15% of diagnoses. Leqembi is not approved for these patients.
Alzheimer's is the most prevalent form of dementia, affecting more than one in nine individuals over the age of 65. It leads to memory loss and worsens over time.
The European Medicines Agency (EMA) declined Leqembi's approval due to the sufficient evidence showing that the risk of severe side effects, such as brain hemorrhages, outweighs its benefits in slowing down cognitive decline. Despite Leqembi's approval in the US and the UK's MHRA giving it the green light, the UK's National Health Service (NHS) will not subsidize it due to its high cost, as determined by the National Institute for Health and Care Excellence (NICE).