FDA accepts for Priority Review New Drug Application for mirabegron oral suspension and supplemental New Drug Application for Myrbetriq (mirabegron) tablets in paediatric patients with neurogenic detrusor overactivity (NDO)

The submissions were based on findings from a phase 3 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

SPS commentary:

In UK, mirabegron is only available as prolonged-release tablets licensed for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder syndrome.

Biospace Inc.