The company states: “Eli Lilly (LLY) announced that the National Medical Products Administration in China has approved Kisunla, an Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease, which includes people with mild cognitive impairment, or MCI, as well as people with the mild dementia stage of Alzheimer’s disease who have confirmed amyloid pathology. China is the fourth major market in which Kisunla has been approved for use, following approvals in the United States, Japan and Great Britain. In China, it is estimated that nearly 6% of people over the age of 65 are living with Alzheimer’s disease and related dementias, with nearly 11% over the age of 65 expected to be living with Alzheimer’s disease by 2050. Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo. Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study. One of the treatment goals of the study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography. If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study. In the TRAILBLAZER-ALZ 2 study, 66% of patients achieved plaque clearance at one year.”
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