Posted by Michael Wonder on 06 Jan 2021
FDA accepts for priority review the new drug application for mirabegron for oral suspension and supplemental new drug application for Myrbetriq (mirabegron) tablets in paediatric patients
6 January 2021 - Astellas Pharma announced today that the U.S. FDA accepted priority review for its new drug application for mirabegron for oral suspension and its supplemental new drug application for Myrbetriq (mirabegron) tablets for the treatment of neurogenic detrusor overactivity in paediatric patients aged three years and older.
The Prescription Drug User Fee Act goal date for a decision by the FDA is 28 March 2021.
The new drug application and supplementary new drug application were based on findings from a Phase 3 pivotal clinical trial that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents (aged 3 to <18 years) with neurogenic detrusor overactivity and using clean intermittent catheterisation.
