In a large, population-based case-control study, researchers identified prescription medications associated with a lower risk for 3 neurodegenerative diseases: Parkinson disease, Alzheimer disease, and amyotrophic lateral sclerosis.
The FDA has approved Qalsody (tofersen) for the treatment of adults with ALS who have a mutation in the SOD1 gene.
Tofersen is an investigational antisense medicine that reduces the synthesis of SOD1 protein production.
The target action dates have been extended by 3 months to allow for extra time to review the applications.
Relyvrio is an oral, fixed-dose coformulation of sodium phenylbutyrate and taurursodiol.
A biomarker for both ALS and FTD, 2 neurological disorders that share clinical, genetic, and pathological traits, can help signal disease onset and the progression of degeneration.
The oral suspension can be administered by mouth or via feeding tube using a 5mL oral syringe that comes with the product.
The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.
Researchers sought to compare various high-caloric food supplements as add-on therapy to normal food intake and standard treatment in patients with ALS.
AMX0035 is an oral, fixed-dose coformulation of sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine.
