The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for mirabegron for oral suspension and the supplemental New Drug Application (sNDA) for mirabegron (Myrbetriq; Astellas) tablets for the treatment of neurogenic detrusor overactivity (NDO) in patients aged 3 years and older.
NDO is a neurological bladder dysfunction commonly observed in children with spina bifida that leads to symptoms of urinary urgency, frequency and incontinence. The NDA and sNDA submissions are supported by data from a pivotal multicenter, open-label phase 3 study that evaluated the efficacy and safety of mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
A Prescription Drug User Fee Act (PDUFA) target date of March 28, 2021 has been set for these applications. “These regulatory submissions mark an important step toward addressing the unmet treatment needs for children with neurogenic detrusor overactivity,” said Salim Mujais, MD, senior vice president and head, Medical Specialties, Astellas.
Myrbetriq, a beta-3 adrenergic agonist, is currently indicated in combination with or without solifenacin succinate for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The product is available as 25mg and 50mg extended-release tablets.
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FDA accepts for Priority Review the New Drug Application for mirabegron for oral suspension and supplemental New Drug Application for Myrbetriq® (mirabegron) tablets in pediatric patients. [press release]. Tokyo, Japan: Astellas Pharma Inc.; January 6, 2021.