Biogen/Eisai's Alzheimer's drug approved by MHRA but not recommended by NICE

Biogen and Eisai's Alzheimer's disease (AD) drug has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat patients in the early stages of the neurodegenerative disease, but has not been recommended for use in the NHS in England and Wales by the National Institute of Health and Care Excellence (NICE).

Leqembi (lecanemab) has been approved 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 However, in a blow to patients, NICE said in draft guidance that the drug's benefits were “too small to justify the cost”.

An estimated 982,000 people in the UK are living with dementia and AD accounts for the majority of cases.

Leqembi is given intravenously every two weeks in a medical facility and works by binding to and reducing clumps of the amyloid-beta protein that form plaques in the brain.

The MHRA's decision makes Leqembi the first medicine approved in the UK that has been shown to slow disease progression. This was supported by results from the late-stage Clarity AD trial, where Leqembi reduced clinical decline by 27% compared with placebo after 18 months.

Eisai, which is responsible for the global development of the drug and the submission of regulatory applications, also recently presented positive three-year data from an open-label extension of the study.

Despite the improvements observed, an independent NICE committee stated: “The cost of the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefit it provides to patients, means that it cannot be considered worthwhile for the taxpayer.”

Alzheimer's Research UK chief executive Hilary Evans-Newton described the news as “bittersweet”.

“It is a remarkable achievement that science is now providing approved treatments that can slow the devastating effects of Alzheimer's rather than just relieve symptoms. However, it is clear that our health care system is not ready to embrace this new wave of Alzheimer's drugs,” she said.

NICE's independent committee will review responses from a public consultation at a second meeting later this year before making its final recommendations.