Limited Drug Exposure Data Halt Accelerated Approval Attempt for Donanemab
Donanemab is an antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG.
Diagnosis & Disease Information
MPR Weekly Dose Podcast Episode #144
FDA grant accelerated approval to Alzheimer disease treatment; New fixed-dose asthma treatment; NERD therapy looks promising; Leukemia drug to be withdrawn in 2023; Pertussis prevention treatment approved for use during pregnancy.
Brexpiprazole Gets Priority Review for Agitation With Alzheimer Dementia
The sNDA is supported by data from two phase 3 studies that evaluated the efficacy and safety of brexpiprazole in patients with agitation associated with Alzheimer dementia.
Leqembi Gets Accelerated Approval for Alzheimer Disease
Leqembi is a humanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
Study Explores Impact of FDA Approval of Aducanumab on Trial Participation
Individuals who were independently aware of the FDA decision demonstrated reduced willingness to participate
MPR Weekly Dose Podcast #139
FDA pulls bebtelovimab EUA; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for Duchenne muscular dystrophy is accepted for Priority Review.
Gantenerumab Fails to Meet Endpoints in Early Alzheimer Disease Trials
Gantenerumab is an investigational immunoglobulin G1 antibody designed to increase the clearance of soluble amyloid beta from the brain.
Antiepileptic Med Use Increasing in Nursing Home Residents With Dementia
The two most common, valproic acid and gabapentin, being used in clinically distinct ways
Telmisartan Linked to Reduced Risk for Alzheimer Disease in Black Patients
African American-specific beneficial effects of telmisartan identified in Mendelian randomization analysis
DaTscan Approved for Use in Patients With Suspected Lewy Body Dementia
DaTscan is a radioactive diagnostic agent that works by binding reversibly to the human dopamine transporter (DaT) in the brain.
