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Just! Eli Lilly Alzheimer's disease antibody therapy is proposed to be included in the breakthrough therapy variety

 Last Update: 2023-02-02
 Source: Internet
 Author: User

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Today (January 9), the official website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration announced that Eli Lilly and Company Donanemab injection, a Class 1 new drug declared by the Company, is intended to be included in the breakthrough therapy variety, which is intended to be used to treat early symptomatic Alzheimer's disease, including mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease
.
According to public information, donanemab targets amyloid plaques called N3pG, β, and has submitted a biological product license application (BLA) in the United States and has been granted priority review by the FDA
.

It is proposed to include breakthrough therapy varieties for the treatment of early symptomatic Alzheimer's disease targeting amyloid plaques β called N3pG

Screenshot source: CDE official website

Donanemab is a monoclonal antibody
that binds to the amyloid β isoform N3pG.
It is able to bind to β amyloid in the brain of Alzheimer's patients, thereby promoting the clearance
of amyloid deposits in the brains of patients.
Previously, Donanemab has been granted breakthrough therapy designation
by the FDA.
In August 2022, the FDA accepted Donanemab's application for marketing authorization for biologics and granted it priority review status for accelerated approval for the treatment of early-stage Alzheimer's disease
.

β amyloid subtype N3pG, it is able to bind to amyloid β in the brain of Alzheimer's patients, thereby promoting the clearance
of amyloid deposits in the brains of Alzheimer's patients.

According to the results of Lilly's earlier biomarker study, donanemab not only leads to rapid clearance of amyloid deposition, but also significantly reduces the level of
P-tau217 in the patient's plasma.
This is an investigational blood biomarker developed by Eli Lilly that is associated
with amyloid and tau pathology and the diagnosis of Alzheimer's disease.
In addition, donanemab was able to reduce levels of
GFAP, an inflammatory biomarker associated with astrocytes in the brain.
These evidence suggests that the drug reduces a variety of pathological processes
associated with Alzheimer's disease.

Significantly reducing plasma levels of P-tau217 in patients donanemab was also able to reduce levels of the inflammatory biomarker GFAP associated with brain astrocytes proliferation

At the Alzheimer's Disease Clinical Trials Conference at the end of 2022, Eli Lilly announced positive data
from Donanemab in a Phase 3 clinical trial.
After 6 months of treatment, donanemab reduced amyloid plaque levels in the brains of patients with early Alzheimer's disease by 65.
2% compared to 17.
0%
in the active control group.
This data shows that Donanemab is able to rapidly and effectively alter the biology
of Alzheimer's disease in the early stages of treatment.

This data shows that Donanemab is able to rapidly and effectively alter the biology of Alzheimer's disease in the early stages of treatment

Results from a Phase 2 clinical trial, previously published in the New England Journal of Medicine, showed that donanemab was able to alleviate the rate
of decline in cognitive and daily living abilities in patients with early-stage Alzheimer's disease.
Meanwhile, positron scanning (PET) imaging showed that donanemab was able to rapidly remove amyloid deposits
from the patient's brain.
After 6 months of treatment, 40% of patients tested negative for PET, meaning that their levels of amyloid deposition in their brains were not significantly different from
those of healthy people.

It can alleviate the decline in cognition and daily living ability in patients with early-stage Alzheimer's disease, and can quickly remove amyloid deposits in the brain

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Eli Lilly Company has initiated an international multi-center (including China), randomized, double-blind, placebo-controlled, phase 3 study in China in September 2022 to evaluate the safety and efficacy
of Donanemab in subjects with early symptomatic Alzheimer's disease (including mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease) in subjects with brain tau protein pathology 。 The Chinese part of the study, led by Jia Jianping, chief physician of Xuanwu Hospital of Capital Medical University, is planned to be carried out in nearly 50 research centers in China, with a target enrollment of 400 people in China
.

Early symptomatic Alzheimer's disease with brain tau protein pathology (including mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease), Chief Physician Jia Jianping of Xuanwu Hospital of Capital Medical University plans to carry out nearly 50 research centers in China, with a target enrollment of 400 people in China

Alzheimer's disease is a common neurodegenerative disease in the elderly, with quite serious and far-reaching negative effects
not only on the patients themselves, but also on their families, communities and society as a whole.
It is hoped that Eli Lilly Donanemab will progress smoothly in clinical research and bring new treatment options
to patients as soon as possible.

Resources:

[1] China Food and Drug Administration Center for Drug Evaluation (CDE) official website.
Retrieved Jan 9， 2023, from

[1] China Food and Drug Administration Center for Drug Evaluation (CDE) official website.
Retrieved Jan 9， 2023, from [2] Eli Lilly announces positive results in the first head-to-head study of Donanemab for early symptomatic Alzheimer's disease.
Retrieved Dec 7, 2022, from https://mp.
weixin.
qq.
com/s/qNizxi4Zox-ko5OR0-KpJw

[2] Eli Lilly announces positive results in the first head-to-head study of Donanemab for early symptomatic Alzheimer's disease.
Retrieved Dec 7, 2022, from https://mp.
weixin.
qq.
com/s/qNizxi4Zox-ko5OR0-KpJw

[3] Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial.
Retrieved Jan 11，2021.
From https://investor.
lilly.
com/news-releases/news-release-details/lillys-donanemab-slows-clinical-decline-alzheimers-disease

[4] China Drug Clinical Trial Registration and Information Disclosure Platform.
Retrieved Sep 5 , 2022.
From

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