Eisai Alzheimer’s drug authorised in UK but still faces obstacles

In partnership with BioArctic AB, pharmaceutical company Eisai has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for its Alzheimer’s disease drug product Leqembi. 

Leqembi, generic name lecanemab, works by removing amyloid beta protein by selectively binding to aggregate species of the protein and neutralising them to clear the proteins from the brain. Amyloid beta proteins are considered a hallmark of Alzheimer’s disease, and is the target of several clinical trials aimed at treating the neurodegenerative disease. In trials, Leqembi demonstrated slowing of cognitive decline by a rate of 27% in Alzheimer’s patients compared with a placebo. 

Leqembi is the first medicine of its kind – targeting the underlying cause of Alzheimer’s disease – to receive approval in a European country. It was previously rejected by the EMA for use in the EU. The MHRA’s approval was based on phase III data from a global clinical trial by Clarity AD, in which the primary endpoint and all key secondary endpoints were met with statistically significant results. Common adverse reactions in the trials were infusion-related reactions, amyloid-related imaging abnormalities with haemorrhage and/or cerebral edema, and headaches.  

However, despite the approval, the National Institute for Health and Care Excellence stated that Leqembi’s high cost and need for intensive monitoring for side effects means “it cannot be considered good value for the taxpayer.” As a result, it is unlikely Alzheimer’s patients will be able to access Leqembi through the UK’s National Health Services (NHS), the region’s state-run health service. In the UK, it is estimated that up to 982,000 people live with dementia, with Alzheimer’s disease constituting 60-70% of those with dementia. This recommendation highlights the latest obstacles in the drug’s journey to approval and highlights the complexities of Alzheimer’s disease drugs. The companies involved did not disclose what information that would provide regulators. 

Despite these hurdles, CEO of BioArctic Gunilla Oswald, who holds the right to commercialise Leqembi in the Nordic region and joint commercialisation in Europe pending approval, stated, “The decision from MHRA to authorise lecanemab is an important step forward for eligible patients in Great Britain who could now for the first time gain access to a treatment, which in studies has been shown to slow the progression of early Alzheimer’s disease. For Alzheimer’s disease patients, time is the most valuable asset, and access to new treatments has potential to offer them just that.” 

Sources: 

1. Leqembi (lecanemab) authorized for early Alzheimer’s disease in Great Britain [Accessed August 22, 2024] https://www.prnewswire.com/news-releases/leqembi-lecanemab-authorized-for-early-alzheimers-disease-in-great-britain-302228486.html 

2. New Alzheimer drug deemed too costly for UK’s state-run health service [Accessed August 22, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/uk-patients-unlikely-get-access-eisai-biogens-alzheimers-drug-2024-08-22/