Astellas Mirabegron was given priority review by the FDA

The Myrbetriq tablet was originally approved in the United States in 2012 to treat adult patients with bladder overactive disorder (OAB) with acute urinary incontinence, urinary urgency, and frequent urinary symptoms.
the drug is a prescription drug that can be used alone or in a joint form with solifenacin succinate.
neurogenic forced urinary muscle over-activity (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 impatience, frequent urination, and urinary incontinence.
, a congenital spinal defect, is a common cause of NDO in children.
NDA and sNDA based on the results of a key Phase 3 clinical study (NCT02751931).
the study was conducted in children and adolescents (aged 3 to 18) who used clean intermittent catheters to assess the efficacy, safety, tolerance and pharmacodynamics of mirabegron.
Salim Mujais, Senior Vice President and Director of Medicine at Astellas, said,
The regulatory documents represent an important step toward addressing the unseeded treatment needs of children with neurogenic urinary excesses (NDO).
limited treatment options for NDO children, Mirabelon has the potential to expand treatment options available for these children, providing a good balance of efficacy and tolerance.
" Original Origin: FDA Accepts for Priority Review The New Drug Application for Mirabegron for Oral Stay and Supplemental New Drug Application for Myrbetriq ® Tablets in Pediatric Patients