Alzheimer's disease (AD) is a degenerative disease of the nervous system whose cause is still unknown
.
Although at present, the drugs on the market are very limited, and most of them are mainly
to improve clinical symptoms.
But over the years, the medical community has never given up cracking Alzheimer's disease, and Eli Lilly, Takeda Pharmaceutical, Merck, Pfizer, Roche, etc.
are all increasing their layout
in this field.
It is understood that at the 15th Alzheimer's Disease Clinical Trial Conference (CTAD) held from November 29 to December 2, Eisai/Biogen, Otsuka Pharmaceutical/Lundbeck, Eli Lilly, etc.
successively released the phase III clinical study data
of innovative drugs under development for Alzheimer's disease (AD).
Otsuka Pharmaceutical/Lundbeck
On December 1, Otsuka Pharmaceuticals and Lundbeck announced the positive efficacy and safety results
of three Phase 3 clinical studies of brexpiprazole at the Alzheimer's Disease Clinical Trials Congress (CTAD).
The data show that the drug can significantly improve agitation symptoms
in Alzheimer's disease patients.
In fact, on June 28 this year, Otsuka Pharmaceutical Co.
, Ltd.
and Lundbeck Pharmaceutical jointly announced positive results
in a Phase 3 clinical trial of brexpiprazole for the treatment of agitation in Alzheimer's disease patients.
Data analysis showed that after 12 weeks of treatment, brexpiprazole achieved a statistically significant improvement in CMAI score changes in assessing agitation symptoms compared with placebo (p=0.
0026).
Based on this positive result, the two companies also plan to submit a supplemental new drug application (sNDA)
to the U.
S.
FDA.
Biogen/Eisai
Lecanemab, the second AD drug jointly developed by Biogen and Eisai, is an anti-amyloid fibrillary antibody that targets amyloid (Aβ), an anti-amyloid fibrillary antibody
for the treatment of mild cognitive impairment caused by AD and mild AD in the brain with confirmed amyloid pathology 。 The results of a large global phase III confirmatory Clarity AD clinical study presented at the CTAD conference showed that multiple indicators in terms of cognition and function, disease progression, health-related quality of life, and caregiver burden suggest that treatment with Lecanemab may have positive benefits
for patients, caregivers, clinicians, and society.
It is reported that as early as May 2021, the FDA granted the drug a breakthrough therapy
for the treatment of AD.
In September 2021, Eisai announced that it began initiating the submission of Lecanemab Rolling Marketing Applications (BLAs)
to FDA through the accelerated approval pathway.
Eli Lilly
On November 30, Eli Lilly also announced all primary and secondary endpoints of the 6-month Phase III trial of the drug Donanemab, providing the first Aduhelm head-to-head comparison for amyloid plaque clearance in patients with early-stage symptomatic Alzheimer's disease
.
The Phase III trial (TRAILBLAZER-ALZ 4) was presented
at the Alzheimer's Disease Clinical Trials (CTAD) meeting.
The primary endpoint was cerebral amyloid plaque clearance (cerebral amyloid plaque level <24.
1 Centiloids).
At 6 months, the proportion was 37.
9% in the Donanemab group and only 1.
6%
in the Aduhelm group.
It is worth mentioning that on June 29 this year, Eli Lilly China announced that its clinical trial application for Donanemab injection in China was approved
by the National Medical Products Administration.
This is a global study
evaluating the safety and efficacy of Donanemab in the treatment of early symptomatic Alzheimer's disease, including mild cognitive impairment due to Alzheimer's disease, as well as mild Alzheimer's disease.
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