TOKYO, January 6, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq® (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2021.
“These regulatory submissions mark an important step toward addressing the unmet treatment needs for children with neurogenic detrusor overactivity. Treatment options for children with neurogenic detrusor overactivity are limited,” said Salim Mujais, M.D., senior vice president and head, Medical Specialties, Astellas. “Mirabegron has the potential to expand the repertoire of treatments available for these children, offering a favorable balance of efficacy and tolerability.”
NDO is a neurological bladder dysfunction caused by nerve damage. Children with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency and incontinence.1 Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.2
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents (aged 3 to <18 years) with NDO and using clean intermittent catheterization (ClinicalTrials.gov Identifier: NCT02751931).
Myrbetriq® tablets were initially approved in 2012 in the United States for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
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