MHRA Approves Biogen/Eisai's Alzheimer's Drug; NICE Doesn't Recommend

Biogen and Eisai’s Alzheimer’s disease (AD) medication, Leqembi (lecanemab), has been approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for treating early stages of the neurodegenerative disease. This approval applies specifically to patients with mild cognitive impairment and mild dementia associated with AD who have one or no copies of the apolipoprotein E4 gene. However, the drug has not been recommended by the National Institute of Health and Care Excellence (NICE) for use within the NHS in England and Wales.

Leqembi functions by binding to and reducing amyloid beta protein clumps that form plaques in the brain, which are characteristic of Alzheimer's disease. It is administered intravenously every two weeks in a healthcare setting. The MHRA's decision is significant as it marks Leqembi as the first drug licensed in the UK shown to slow the progression of Alzheimer’s disease. This approval was backed by the results from the Clarity AD trial, which demonstrated a 27% reduction in clinical decline at 18 months compared to a placebo.

Despite these promising results, NICE has expressed reservations in its draft guidance, stating that the benefits provided by Leqembi are “too small to justify the costs.” This is particularly disappointing news for the approximately 982,000 people in the UK living with dementia, most of whom suffer from Alzheimer's disease.

Eisai, the company leading the drug's development and regulatory submissions globally, also recently shared positive data from a three-year open-label extension of the Clarity AD study. Nevertheless, an independent NICE committee highlighted the high costs involved in providing the treatment. These costs include the fortnightly hospital infusions and the intensive monitoring required for side effects, which, combined with the relatively modest benefits, led NICE to conclude that the drug does not offer good value for taxpayers.

Hilary Evans-Newton, Chief Executive of Alzheimer’s Research UK, described the situation as "bittersweet." She acknowledged the significant progress in developing treatments that can slow down Alzheimer’s effects rather than merely alleviating symptoms. However, she also pointed out that the current health system is not prepared to handle this new wave of Alzheimer’s treatments.

Professor Andy Whiting from Durham University and CEO of Nevrargenics, a company focused on developing drugs for neurodegenerative diseases, remarked on the need for the biotech and pharmaceutical industries to better balance cost and effectiveness in drug development. He noted that while Leqembi targets the symptoms by addressing the plaques, it does not tackle the underlying causes of these plaques. For a drug to be truly valuable, it needs to have a greater impact, which means developing treatments that address the root causes of neurodegenerative diseases rather than just the symptoms.

NICE's independent committee will review responses from a public consultation in a second meeting scheduled for later this year before issuing its final recommendations. This ongoing evaluation will determine whether Leqembi will ultimately be recommended for use in the NHS, potentially offering some hope for individuals affected by Alzheimer’s disease.