FDA Issues Complete Response Letter for Libervant
Libervant is a buccally administered soluble film of diazepam used to treat acute uncontrolled seizures in patients with refractory epilepsy on stable AED regimens.
Neurological Disorders
MPR Weekly Dose Podcast Episode 47
This week we have remdesivir news; A new opioid and spinal muscular atrophy treatments are approved; A sublingual epinephrine treatment; And the latest on Biogen’s investigational Alzheimer disease treatment. Also, we have a brief summary of the other drugs in the pipeline from the past week.
Aducanumab BLA for Alzheimer Disease Submitted for FDA Review
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
Novel Therapy for Alzheimer Disease Agitation Gets Breakthrough Designation
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
First Diagnostic Agent Approved to Image Tau Pathology in Patients Being Evaluated for Alzheimer Disease
Tauvid is indicated for use with positron emission tomography (PET) imaging of the brain.
Gene Therapy for Frontotemporal Dementia With a GRN Mutation Gets Fast Track Status
The FDA has granted Fast Track designation to PR006 (Prevail Therapeutics), an experimental gene therapy, to slow the progression of frontotemporal dementia with a GRN mutation.
First Generic Versions of Gilenya Get FDA Approval
The FDA has approved the first generic versions of Gilenya (fingolimod; Novartis) for the treatment of relapsing forms of multiple sclerosis in adults.
FDA to Review Satralizumab for Neuromyelitis Optica Spectrum Disorder
The FDA has accepted the Biologics License Application (BLA) for satralizumab (Genentech) for the treatment of neuromyelitis optica spectrum disorder.
Donepezil Ups Risk for Hospital Admission for Rhabdomyolysis
Donepezil linked to increased risk for admission with rhabdomyolysis versus rivastigmine, galantamine
