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▎Editor of WuXi AppTec's content team On September 27, Eisai and Biogen jointly announced that they have submitted a rolling submission for the treatment of early-stage Alzheimer's disease (AD) antibodies to the US FDA through the accelerated approval channel Biological product license application (BLA) for the therapy lecanemab (BAN2401)
.
In June of this year, lecanemab was granted a breakthrough therapy designation by the FDA.
After that, Eisai and the FDA reached an agreement to roll out lecanemab's BLA through the accelerated approval channel
.
The marketing application is mainly based on the clinical, biomarker and safety data of lecanemab's Phase 2b clinical trial (Study 201) in patients with early AD
.
The trial included 856 patients with mild cognitive impairment (MCI) due to AD or mild AD, and they confirmed the presence of amyloid pathology
.
The test results show that the highest dose (10 mg/kg) of lecanemab can significantly reduce the level of amyloid in the patient's brain, reducing brain amyloid by 0.
306 SUVr units at 18 months of treatment (baseline average value is 1.
37)
.
▲Different doses of lecanemab caused changes in amyloid levels in the phase 2b clinical trial (picture source: reference [2]).
Patients who received placebo in the trial, switched to lecanemab during the extended trial, showed amyloid Protein levels also showed reduced results
.
In addition, lecanemab was well tolerated in the trial, and the incidence of amyloid-related imaging abnormalities, edema, and effusion at 10 mg/kg every two weeks was 9.
9%
.
In terms of testing the rate of cognitive decline in patients, this trial did not reach the pre-set primary endpoint
.
The Phase 3 clinical trial of Lecanemab for early AD (Clarity AD) is underway, and 1795 patients were enrolled in March 2021
.
The US FDA agrees that the final results of the clinical trial can be used as a corroborative study to verify the clinical benefits of lecanemab to further support BLA
.
Mr.
Haruo Naito, CEO of Eisai, said: “As the global population grows and ages, the number of AD patients is on the rise
.
AD not only brings a huge burden to patients and their families, but also a huge burden to society
.
We .
Recognizing the strong and urgent expectations of stakeholders for further advancement of the treatment of this disease
.
For many years, Eisai has been working hard to develop new therapies
.
We are committed to bringing new drugs to AD patients and their families as soon as possible
.
"About lecanemab Lecanemab is a kind of The humanized monoclonal antibody intended for the treatment of AD is the result of the collaborative research and development of Eisai and BioArctic
.
Lecanemab selectively binds to and eliminates amyloid aggregates (fibrils), which are believed to accelerate the neurodegenerative process of AD
.
Therefore, lecanemab may have an impact on the pathology of the disease and slow down the progression of the disease
.
Reference: [1] Eisai Initiates Rolling Submission To The US FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway.
Retrieved 2021-09-28, from https:// /news-releases/eisai-initiates-rolling-submission-to-the-us-fda-for-biologics-license-application-of-lecanemab-ban2401-for-early-alzheimers-disease-under-the-accelerated-approval -pathway-301386121.
html[2] Swanson et al.
, (2021).
A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody.
Alzheimer's Research & Therapy, https://doi.
org/10.
1186/s13195-021-00813-8 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
In June of this year, lecanemab was granted a breakthrough therapy designation by the FDA.
After that, Eisai and the FDA reached an agreement to roll out lecanemab's BLA through the accelerated approval channel
.
The marketing application is mainly based on the clinical, biomarker and safety data of lecanemab's Phase 2b clinical trial (Study 201) in patients with early AD
.
The trial included 856 patients with mild cognitive impairment (MCI) due to AD or mild AD, and they confirmed the presence of amyloid pathology
.
The test results show that the highest dose (10 mg/kg) of lecanemab can significantly reduce the level of amyloid in the patient's brain, reducing brain amyloid by 0.
306 SUVr units at 18 months of treatment (baseline average value is 1.
37)
.
▲Different doses of lecanemab caused changes in amyloid levels in the phase 2b clinical trial (picture source: reference [2]).
Patients who received placebo in the trial, switched to lecanemab during the extended trial, showed amyloid Protein levels also showed reduced results
.
In addition, lecanemab was well tolerated in the trial, and the incidence of amyloid-related imaging abnormalities, edema, and effusion at 10 mg/kg every two weeks was 9.
9%
.
In terms of testing the rate of cognitive decline in patients, this trial did not reach the pre-set primary endpoint
.
The Phase 3 clinical trial of Lecanemab for early AD (Clarity AD) is underway, and 1795 patients were enrolled in March 2021
.
The US FDA agrees that the final results of the clinical trial can be used as a corroborative study to verify the clinical benefits of lecanemab to further support BLA
.
Mr.
Haruo Naito, CEO of Eisai, said: “As the global population grows and ages, the number of AD patients is on the rise
.
AD not only brings a huge burden to patients and their families, but also a huge burden to society
.
We .
Recognizing the strong and urgent expectations of stakeholders for further advancement of the treatment of this disease
.
For many years, Eisai has been working hard to develop new therapies
.
We are committed to bringing new drugs to AD patients and their families as soon as possible
.
"About lecanemab Lecanemab is a kind of The humanized monoclonal antibody intended for the treatment of AD is the result of the collaborative research and development of Eisai and BioArctic
.
Lecanemab selectively binds to and eliminates amyloid aggregates (fibrils), which are believed to accelerate the neurodegenerative process of AD
.
Therefore, lecanemab may have an impact on the pathology of the disease and slow down the progression of the disease
.
Reference: [1] Eisai Initiates Rolling Submission To The US FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway.
Retrieved 2021-09-28, from https:// /news-releases/eisai-initiates-rolling-submission-to-the-us-fda-for-biologics-license-application-of-lecanemab-ban2401-for-early-alzheimers-disease-under-the-accelerated-approval -pathway-301386121.
html[2] Swanson et al.
, (2021).
A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody.
Alzheimer's Research & Therapy, https://doi.
org/10.
1186/s13195-021-00813-8 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
