(Updates headline and text throughout; reconsideration also applies to BioArctic)
The UK's drug regulator, NICE, is set to reconsider its decision not to recommend Eli Lilly's Alzheimer's drug donanemab and BioArctic's lecanemab for use within the National Health Service (NHS).
While the drugs were approved in the UK in 2024, they were initially deemed to offer insufficient clinical benefit relative to their cost for NHS implementation.
Following appeals by Eli Lilly and Eisai (BioArctic's partner), the agency will now review several factors, including the impact on caregivers' quality of life, NHS infusion costs, and long-term data for donanemab.
"Today's decision is an opportunity for NICE to consider the true cost of Alzheimer's disease on individuals and their families, and we welcome the decision to re-examine whether these new treatments could be provided by the NHS," said David Thomas, Head of Policy and Public Affairs at Alzheimer's Research UK.
BioArctic AB is a Sweden‑based biopharmaceutical company specializing in the discovery and development of disease‑modifying treatments for neurodegenerative disorders. The Company’s primary focus is on conditions that affect the central nervous system (CNS), including Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS), areas characterized by high unmet medical need and limited effective therapies. BioArctic AB conducts advanced research and development of innovative biological drugs, with a particular emphasis on monoclonal antibodies designed to target the underlying disease mechanisms rather than only alleviating symptoms. The Company combines in‑house scientific expertise with strategic collaborations with global pharmaceutical partners to advance and commercialize its therapeutic candidates worldwide.
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