Thursday, the U.K.'s Medicines and Healthcare products Regulatory Agency approved Eisai Co., Ltd (OTC:ESAIY) (OTC:ESALF) and Biogen Inc's (NASDAQ:BIIB) Leqembi (lecanemab).
Lecanemab is indicated for mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
Also Read: Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events.
Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD) that targets an underlying cause of the disease to be authorized in a European country.
In the United Kingdom, it is estimated that 982,000 people are living with dementia, and AD is the cause in 60-70% of people with dementia.
Despite the approval, the National Institute for Health and Care Excellence (NICE), in its guidance draft, said, " benefits of the new Alzheimer's drug lecanemab are too small to justify the costs."
NICE's independent committee heard that it is the first medicine to be licensed in the UK that has been shown to slow down the progression of the disease by between 4 and 6 months.
The agency said it is not recommending lecanemab for use on the NHS because it is not a cost-effective use of limited NHS funding.
The draft added the clinical trial evidence lecanemab has a small but meaningful 4-6 months effect on delaying cognitive decline when added to existing treatment.
Because the clinical trial only reported outcomes when people had been taking lecanemab for 18 months, there is a lack of evidence on its long-term effects.
"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," the independent NICE committee has said.
Price Action: BIIB stock is down 2.01% at $202.04 at the last check on Thursday.
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