Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.