ALPMF - Astellas wins FDA approval for new Myrbetriq indication and formulation

Astellas Pharma ([[ALPMF]]) announced that the FDA has approved Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) for neurogenic detrusor overactivity (“NDO”) in children aged three years and older.The decision was backed by the positive data from a Phase 3 pivotal study that evaluated mirabegron in children and adolescents (aged 3 to <18 years) with NDO and using clean intermittent catheterization, the company said.A type of bladder dysfunction, NDO can cause urinary frequency, urgency, and incontinence, and 85% of children with NDO have spina bifida, a congenital defect in the spinal cord.Myrbetriq Granules are expected to be available in the U.S. by the end of 2021, and the company’s 2021 fiscal forecast already reflects the impact of the FDA decision.Explaining the effect of approval on patients with a high unmet need, Salim Mujais, Astella’s head of Medical Specialties noted: “since its initial approval nine years ago, Myrbetriq

For further details see:

Astellas wins FDA approval for new Myrbetriq indication and formulation