Meta-Analysis Shows Decrease in Dementia Risk With HTN Treatment
Lowering blood pressure with antihypertensive treatment may reduce risk for incident dementia in older adults with a history of hypertension
Lowering blood pressure with antihypertensive treatment may reduce risk for incident dementia in older adults with a history of hypertension
The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.
In Mendelian randomization analyses, 25(OH)D associated with risk for dementia, but not stroke or neuroimaging outcomes
Most neurological disorders do not appear to be more frequent after COVID-19 than after influenza or bacterial pneumonia
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
Although not bound by the committee’s recommendations, the Agency does take them into consideration when making decisions on approval.
Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.
To address the issues raised in the CRL, the Company provided additional analyses from the HARMONY and Study-019 trials.
In randomized, double-blind trial, no difference seen in scores for agitated behaviors at 12 weeks with mirtazapine versus placebo
Risk for dementia decreased for cases and controls younger than 80 years who had been taking estrogen-only therapy for 10 years or more