FDA Rejects Pimavanserin sNDA for Alzheimer Disease Psychosis
The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.
Dementia
Genetic Analyses Link Vitamin D Deficiency to Dementia Risk
In Mendelian randomization analyses, 25(OH)D associated with risk for dementia, but not stroke or neuroimaging outcomes
COVID-19 Linked to Increased Risk of Neurological Disorders
Most neurological disorders do not appear to be more frequent after COVID-19 than after influenza or bacterial pneumonia
Reduction in Vial Size of Aducanumab Could Yield Savings
Savings would range from $70.9 to $369.0 million annually if the 300 mg/3.0 mL vial was reduced to 100 mg/1.0 mL
FDA Panel Votes on Pimavanserin for Alzheimer Disease Psychosis
Although not bound by the committee’s recommendations, the Agency does take them into consideration when making decisions on approval.
FDA Sets Date for Decision on Pimavanserin for Alzheimer Disease Psychosis
Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.
Pimavanserin sNDA Resubmitted for Alzheimer Disease Psychosis
To address the issues raised in the CRL, the Company provided additional analyses from the HARMONY and Study-019 trials.
Mirtazapine Does Not Reduce Agitation in Dementia Patients
In randomized, double-blind trial, no difference seen in scores for agitated behaviors at 12 weeks with mirtazapine versus placebo
Risk for Dementia Not Increased With Menopausal Hormone Therapy
Risk for dementia decreased for cases and controls younger than 80 years who had been taking estrogen-only therapy for 10 years or more
Dietary Flavonoids May Lower Odds of Subjective Cognitive Decline
Associations strongest for flavones, flavanones, anthocyanins; dose-response curve steepest for flavones, then anthocyanins
