FDA Panel Votes on Daprodustat for Anemia of Chronic Kidney Disease
The NDA was supported by data from the ASCEND clinical program, which included dialysis and nondialysis patients.
Neurological Disorders
MPR Weekly Dose Podcast Episode #131
Approvals in psoriasis, hepatorenal syndrome, and neutropenia; novel therapy gains Priority Review for Rett Syndrome; and the effects of multivitamin supplementation assessed in cognitive function.
Daily Multivitamin Improves Cognition in Older Adults, Says Large Study
The COSMOS-Mind study included 2262 participants and evaluated the effects of cocoa extract and multivitamin-mineral supplementation on cognitive function.
Ublituximab Bests Teriflunomide in Relapsing Multiple Sclerosis
About 48 percent of participants receiving ublituximab had infusion-related reactions
FDA Needs More Data on Sulopenem for Uncomplicated UTI
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
AAN: Race May Affect Response to Anti-CD20 Therapy for MS, NMOSD
B-cell repopulation occurs more often in African American vs White patients between 6 and 12 months after anti-CD20 infusion
Panzyga Approved for Chronic Inflammatory Demyelinating Polyneuropathy
The approval was based on data from a study that compared 2 different maintenance dosages of Panzyga in 142 adults with CIDP.
Experimental Drug for Alzheimer Disease Shows Promise
After six to 12 months of treatment with the drug, patients no longer had amyloid protein plaques.
Trehalose Designated Orphan Drug for ALS
SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide that crosses the blood brain barrier, stabilizes proteins and activates autophagy.
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.
