23 August 2024 | Friday | News
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The Alzheimer's Association welcomes decision by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to approve Leqembi® (lecanemab) for the treatment of Alzheimer's disease. However, while celebrating this milestone — the first Alzheimer's disease modifying treatment approved in the U.K. — the decision by the National Institute for Health and Care Excellence (NICE) to deny access through the National Health Service (NHS) will deepen global health inequity.
"Today is a day of mixed emotions for many in the U.K.," said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "Today's approval decision could provide people living with this fatal and devastating disease the possibility of more time, but this is only possible if people have access to this treatment."
In its decision, MHRA confirms what the scientific community and multiple other health regulatory agencies have long known — lecanemab is safe, effective and beneficial for people in the early stages of Alzheimer's or living with mild cognitive impairment (MCI). The U.K. joins the U.S., China, South Korea, Israel, Hong Kong and Japan in its approval of Leqembi.
"It is baffling that the NICE has decided to deny its taxpayers the option of treatment. It is out-of-step with the science, it is in contrast to the decisions of other regulatory agencies, including here in the U.S., and it is just plain wrong," said Pike. "We strongly urge the NICE to change its decision immediately."
Leqembi works by targeting amyloid beta, the primary component of amyloid plaques, which are a disease-defining hallmark in the brains of people with Alzheimer's disease. Well-conducted clinical trials clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer's.
"Despite the setback of lack of coverage, today's approval is an important milestone for Alzheimer's treatment that should be celebrated. Still, more therapies that target the disease from all angles are needed," Pike added. "We just heard many exciting advancements in Alzheimer's and dementia therapies and diagnostic tools at a record breaking Alzheimer's Association International Conference® (AAIC®) and know the future of Alzheimer's and dementia treatment is promising."
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