Biogen and Eisai’s Alzheimer’s disease (AD) drug has been recommended by the European Medicines Agency’s human medicines committee to treat patients with early stages of the neurodegenerative disorder.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that lecanemab be used in adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD who have one or no copies of the apolipoprotein E4 gene.
The decision comes after Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, requested a re-examination of the prior negative opinion adopted by the CHMP in July.
The new recommendation was supported by positive results from the late-stage global Clarity AD, in which lecanemab reduced clinical decline by 31% at 18 months compared to placebo in the recommended indicated population.
This was measured using the global cognitive and functional scale, CDR-S, which looks at six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies, as well as personal care.
The European Commission will now consider the CHMP’s recommendation as it makes a final decision on lecanemab in early AD.
Affecting an estimated 6.9 million people in Europe, AD is a progressive disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Administered intravenously, Leqembi works by binding to and reducing clumps of amyloid beta protein that form plaques in the brain.
The CHMP’s decision comes three months after lecanemab received approval from the Medicines and Healthcare products Regulatory Agency to treat early AD. However, the drug was not recommended by the National Institute of Health and Care Excellence for use on the NHS in England and Wales, with the health technology assessment agency stating in draft guidance that the its benefits are “too small to justify the costs”.
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.