Nerivio Device Cleared for Migraine in Adolescents
The approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine.
Pediatrics
Novel Therapy Fast Tracked for GI Dysfunction in Peds Undergoing Heart Surgery
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery.
Mirabegron Granted Priority Review for Neurogenic Detrusor Overactivity
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
Kineret Approved for Deficiency of IL-1 Receptor Antagonist
Kineret blocks the biologic activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the IL-1 type I receptor.
Xeomin Approved for Pediatric Patients With Chronic Sialorrhea
The sBLA approval was based on data from a phase 3 study evaluating Xeomin in 216 patients aged 6 to 17 years with chronic sialorrhea associated with cerebral palsy, other genetic or congenital disorders, or traumatic brain injury.
No Significant Difference Between Sitagliptin, Placebo in Pediatric T2D Trials
The alert was based on data from three 20-week double-blind, placebo-controlled studies each with 34-week extensions.
Mucinex Children’s FreeFrom OTC Cough/Cold Products Now Available
Mucinex® Children’s FreeFrom™, a new line of over-the-counter cough and cold products free from artificial flavors, colors, and dyes, has been made available by Reckitt Benckiser.
More Than One-Third of Children With SARS-CoV-2 Are Asymptomatic
Cough, rhinorrhea not predictive of positive test; anosmia/ageusia, nausea/vomiting, headache, fever were most predictive
Novel Treatment Gains Accelerated Approval for Relapsed/Refractory Neuroblastoma
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
Alkindi Sprinkle Now Available for Pediatric Adrenocortical Insufficiency
Alkindi Sprinkle contains immediate-release oral hydrocortisone granules designed for the dosing needs of pediatric patients with adrenocortical insufficiency.
