What is the story behind the landing of a new drug for Alzheimer's disease in Lecheng, Hainan?

Tech 2023-10-12 15:24:15 Source: Network

In the battle against Alzheimer's disease, amyloid research has always been a vanguard force. The clinical drugs derived from these studies mainly target amyloid protein monoclonal antibodies

In the battle against Alzheimer's disease, amyloid research has always been a vanguard force. The clinical drugs derived from these studies mainly target amyloid protein monoclonal antibodies.

Recently, the target amyloid protein monoclonal antibody has frequently made headlines, mainly focusing on a new drug called "lencanemab" (commonly known as Lecanemab, trade name Leqembi). In January 2023, it obtained "accelerated approval" from the US Food and Drug Administration (FDA). On July 6th, it obtained "full approval" from the FDA.

Lenkanezumab has become the news focus, attracting attention to targeted amyloid protein therapy. What is targeted amyloid protein therapy? What is the significance of obtaining "complete approval" for lenkanomib? This article will explain this.

Amyloid protein is a "junk protein"

The formation of amyloid protein is a unique and important feature in the brain of Alzheimer's disease patients. Amyloid protein is a viscous molecule that aggregates into blocks. A large amount of evidence suggests that when amyloid proteins aggregate into blocks, they can cause inflammatory reactions and lead to neuronal death. Firstly, it should be noted that they should have existed in a different way. They were originally another protein embedded in the neuronal cell membrane, but they detached from the structure and became floating bodies after detachment. Once they float freely, they gather together to form larger structures, becoming sticky aggregates that accumulate in the gaps between brain cells. This is the early appearance of amyloid protein.

In the early stages, if these proteins cannot be cleared by special enzymes, plaques will form in the later stages. Over time, these plaques will subsequently trigger a series of fatal reactions: they trigger neuroinflammation and produce a large amount of toxic tau. This series of reactions can lead to neuronal death. After the death of Alzheimer's disease patients, these plaques can be found in the brain of the corpse.

Plaques formed by amyloid protein. Image provided by the author of this article

Continuous research and accumulation of achievements

Due to its importance, the academic community has not stopped researching amyloid proteins. Over the years, rich research has been accumulated in this field, and recently many have been added, such as:

Target amyloid protein therapy

The drugs developed based on these studies are collectively referred to as target amyloid protein drugs. The mechanism of action of this type of drug is similar: to control or improve the progression of disease by eliminating amyloid protein. The most noteworthy drug in this category is lenkanemib. Evidence shows that lenkanomib has highly significant statistical significance in reducing clinical cognitive decline.

oneThere was a statistically significant difference after 6 months of treatment;

After 18 months of treatment, the magnitude of cognitive decline decreased by 27% (compared to patients who did not take medication).

The 'cognitive decline' here is mainly evaluated based on CDR-SB. CDR-SB is a digital scale used to quantify the various severity levels of dementia. Based on interviews with AD patients and their families/caregivers, qualified medical professionals evaluated cognitive and functional performance in six areas: memory, orientation, judgment and problem-solving abilities, community affairs, household and hobbies, and personal self-care abilities. The total score of the six fields is the score of CDR-SB, which is also used as a suitable scale to evaluate the effectiveness of therapeutic drugs targeting the early stages of AD.

ClarityAD Research

The evidence for the above treatment outcomes comes from a large study called ClarityAD:

ClarityAD is a placebo-controlled global multicenter study targeting early Alzheimer's disease patients.

2. A total of 1795 patients were included globally, including different races. The subjects were assigned to the placebo group or treatment group in a 1:1 ratio.

3. The treatment group was given 10mg/kg of lenkanemib every two weeks. The baseline characteristics of the placebo group and the lenkanomib group were similar and matched.

At 6 months of treatment, there was a statistically significant difference between the lenkanomib group and the placebo group. All key secondary endpoints also showed statistically significant improvements.

After 18 months of treatment, the treatment group achieved the primary endpoint (clinical decline amplitude, as assessed by CDR-SB, as explained later), and the decline amplitude was reduced by 27% compared to the placebo group.

Starting from 6 months, and at all time points, the above differences persist.

7. The ARIA incidence rate of rankanab (symptomatic 2.8%, imaging 12.5%) is within the expected range.

Amyloid protein forms and aggregates in the brain of Alzheimer's disease patients, and lenkanomib is a drug that targets amyloid protein. The latest research shows that lenkanomib can alleviate cognitive decline and has shown significant clinical effects in large-scale studies.

Lenkanezumab has been fully approved by the US FDA, indicating that the drug has undergone more comprehensive research and data to demonstrate its safety and efficacy. The federal medical insurance will cover the cost of lencamab, which will have a significant impact on the clinical situation of Alzheimer's disease and enable doctors to better respond to the disease. In addition, lenkanemib has successfully entered the US healthcare system, providing a reference for its application in China and is expected to receive approval from China as soon as possible, benefiting more Chinese patients and their families.

(The author Yang Zhao is an attending physician in the Department of Neurology at Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. His main research interests include neuromuscular diseases and neuroimmune diseases, and he is skilled in the diagnosis and treatment of common, rare, and complex diseases in the field of neurology. Currently, he is a member of the Neuromyopathy and Electrophysiology Group of the Neurology Specialized Branch of the Shanghai Medical Association.)

References:

one
https://www.nytimes.com/2023/07/06/health/alzheimers-leqembi-medicare.html (New York Times, July 6, 2023)

2. UPDATEINFORMATION: June92023: Meeting of the Peripheral and Central Nervous SystemDrugsAdvisoryCommitteeMeetingAnnouncement.RetrievedJune82023, fromhttps://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-information-june-9-2023-meeting-peripheral-and-central-nervous-system-drugs-advisory#event -Materials

3. DAadcommandsunanimouslyinvarofullapproval for Eisai'snewAlzheimer's drug. RetrievedJune92023 fromhttps://endpts.com/fda-adcomm-votes-unanimously-in-favor-of-full-approval-for-eisais-new-alzheimers-drug/

Disclaimer: The content of this article is sourced from the internet. The copyright of the text, images, and other materials belongs to the original author. The platform reprints the materials for the purpose of conveying more information. The content of the article is for reference and learning only, and should not be used for commercial purposes. If it infringes on your legitimate rights and interests, please contact us promptly and we will handle it as soon as possible! We respect copyright and are committed to protecting it. Thank you for sharing.(Email:[email protected])

Mobile advertising space rental

Tag: the What is story behind landing of new drug