-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
▎WuXi AppTec content team editor
Otsuka Pharmaceutical and Lundbeck jointly announced that the US FDA ruled that the Supplemental New Drug Application (sNDA) for brexpiprazole for the treatment of Alzheimer's dementia-related agitation symptoms (agitation) is complete enough.
A substantive review
could be undertaken.
FDA has included the application in a priority review and has set a target review date for its PDUFA of May 10
, 2023.
In addition, the FDA said it is currently planning to convene an advisory committee meeting on psychotropic substances to discuss the application
.
Neuropsychiatric symptoms of Alzheimer's disease, such as agitation, are associated with poor care outcomes such as reduced quality of life and poorer health
.
Agitation is a common neuropsychiatric symptom
of Alzheimer's dementia.
It is reported in approximately 45% of people with Alzheimer's disease dementia, and agitation has a serious impact on the quality of life
for patients, their families and caregivers.
Agitation encompasses a broad category of behaviors that occur in people with Alzheimer's disease and refers to excessive/inappropriate manifestations of normal human emotions and behaviors, including pacing, gesturing, swearing, yelling, pushing, and hitting
.
Brexpiprazole was originally discovered by Otsuka and is currently being developed
jointly by Otsuka and Lundbeck.
The mechanism of action of the drug is currently unknown, but its efficacy may be achieved by partial agonist activity on 5-HT1A and dopamine D2 receptors, as well as binding to the antagonist effects of norepinephrine alpha1B/2C receptors and 5-HT2A receptors
.
Brexpiprazole was approved in the United States on July 10, 2015, as an adjunct to antidepressants in adults with depression and as a therapy
for adult schizophrenia.
Brexpiprazole was also approved by Health Canada in 2017 and by the European Medicines Agency (EMA) in 2018 for the treatment of
schizophrenia.
The submission of sNDA is based on positive data from two Phase 3 clinical trials investigating brexpiprazole in patients with Alzheimer's disease-type dementia-associated agitation symptoms
.
One trial called 331-12-283 showed that 2 mg/day brexpiprazole was statistically superior to placebo treatment (P<0.
05) in terms of mean change in the Cohen-Mansfield Agitation Questionnaire (CMAI)
score from baseline to week 12, its primary endpoint 。 In this trial, brexpiprazole at doses of 2 mg and 3 mg per day showed a statistically significant improvement (p<0.
05)
in the primary efficacy endpoint, mean change in CMAI score from baseline to week 12.
Dr.
John Kraus, Executive Vice President and Chief Medical Officer of Otsuka's R&D and Commercialization Division, said in a press release: "The agitated symptoms associated with Alzheimer's disease dementia are complex and difficult for both patients and caregivers to manage
.
There is an urgent need for new treatments
in this area.
Our commitment to our patients is unwavering, and we are working hard to provide them and their caregivers with a treatment option
that helps reduce agitated symptoms.
”
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
.
If you have relevant business needs, please click the picture below to fill in the specific information
.
