The Food and Drug Administration (FDA) has priority review of the new drug application (NDA) for mirabegron for oral suspension and the complementary new drug application (sNDA) for mirabegron tablets (Myr Betriq; Astellas) for the treatment of overactivity of neurogenic detrusors (NDO) in patients from 3 years.
NDO is a neurologic bladder dysfunction often seen in children with spina bifida, causing symptoms of urination, frequency, and incontinence. The NDA and sNDA filings are supported by data from a pivotal, multicenter, open-label, Phase 3 study evaluating the efficacy and safety of mirabegron in 91 patients aged 3 to 17 years with NDO using clean intermittent catheterization.
A target date of the Prescription Drug User Fee Act (PDUFA) of March 28, 2021 has been set for these applications. “These filings are an important step in meeting the unmet treatment needs of children with neurogenic detrusor overactivity,” said Dr. med. Salim Mujais, Senior Vice President and Head of Medical Specialties, Astellas.
Myr Betriq, a beta-3 adrenergic agonist, is currently indicated in combination with or without solifenacin succinate to treat an overactive bladder with symptoms of urinary incontinence, urgency and urinary frequency. The product is available as 25 mg and 50 mg prolonged-release tablets.
Please visit astellas.com for more information.
The FDA accepts the new drug use for Mirabegron for oral suspension and the complementary new drug use for Myr Betriq® (Mirabegron) tablets in pediatric patients for priority review. [press release]. Tokyo, Japan: Astellas Pharma Inc .; January 6, 2021.
This article originally appeared on MPR
Treatments for Neuromuscular Disorders