FDA Rejects Pimavanserin sNDA for Alzheimer Disease Psychosis
The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.
Neurologic Disorders
Monoclonal Antibodies No Better Than Placebo for Early Parkinson Disease
Two studies show lack of benefit in primary or secondary end points with cinpanemab or prasinezumab versus placebo
Ztalmy Oral Suspension Now Available for CDKL5 Deficiency Disorder
The approval was based on data from the phase 3 Marigold study that included patients aged 2 to 19 years with genetically confirmed CDKL5 gene mutation.
Tofersen Gets Priority Review for Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis
Tofersen is an investigational antisense medicine that reduces the synthesis of SOD1 protein production by binding to SOD1 mRNA, allowing for its degradation by RNase-H.
Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
Opioid Rx Dosage Higher for Adults With Cerebral Palsy, Spina Bifida
Higher prescription of oral morphine equivalents seen for adults with cerebral palsy, spina bifida across pain categories
![HYQVIA (immune globulin [human] 10% with recombinant human hyaluronidase) by Baxter and Halozyme](https://www.empr.com/wp-content/uploads/sites/7/2018/12/hyqviaarticle_656631.png)
Hyqvia Reduces Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Trial
The ADVANCE-1 trial included adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IVIG therapy for at least 3 months prior to screening.
Acadia Seeks Approval for Rett Syndrome Treatment Trofinetide
Trofinetide is a novel synthetic analogue of the amino-terminal tripeptide of IGF-1 designed to reduce neuroinflammation and supporting synaptic function.
Oral Suspension Formulation of Zonisamide Gets FDA Approval
The approval was based on a bioavailability study comparing the efficacy of Zonisade oral suspension to zonisamide capsules in healthy individuals.
