Nevrargenics Ltd.

Biogen and Eisai’s Alzheimer’s disease (AD) drug has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat patients with early stages of the neurodegenerative disease, but has not been recommended by the National Institute of Health and Care Excellence (NICE) for use on the NHS in England and Wales. Leqembi (lecanemab) has been authorised by the MHRA to treat mild cognitive impairment and mild dementia due to AD in adults who have one or no copies of the apolipoprotein E4 gene. However, in a blow to patients, NICE has stated in draft guidance that the drug’s benefits are “too small to justify the costs”. An estimated 982,000 people in the UK are living with dementia and AD accounts for the majority of cases. Administered intravenously in a healthcare setting every two weeks, Leqembi works by binding to and reducing clumps of amyloid beta protein that form plaques in the brain. The MHRA’s decision makes Leqembi the first medicine to be licensed in the UK that has been shown to slow progression of the disease and was supported by results from the late-stage Clarity AD trial, in which Leqembi reduced clinical decline by 27% compared with placebo at 18 months. Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, also recently presented positive three-year data from an open-label extension of the study. Despite the improvements observed, an independent NICE committee said: “The costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients means it cannot be considered good value for the taxpayer.” Alzheimer’s Research UK’s chief executive, Hilary Evans-Newton, described the news as “bittersweet”. “It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms. However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs,” she said. Professor Andy Whiting, emeritus professor at Durham University and chief executive officer and co-founder of Nevrargenics, a Durham spinout company developing drugs for neurodegenerative diseases including Alzheimer’s, said in response to today’s news: “While the MHRA approval of [Leqembi] is obviously a step forward for the pharma industry, the NICE rejection reinforces the need for the biotech and pharma community to focus on better balancing of cost versus effectiveness in drug development. “[Leqembi] only targets the symptoms – the plaques – rather than the cause of those plaques. For a new drug to provide value, the impact needs to be higher, which requires our industry to develop bolder drugs for neurodegeneration that target the cause of the disease, not just the symptoms.” NICE’s independent committee will consider responses from a public consultation at a second meeting later this year before producing its final recommendations.