A new US indication has been approved for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO) in children ages three years and older.
The Astellas (TYO: 4503) drugs are first-in-class to now be US Food and Drug Administration (FDA)-approved for children with NDO, a bladder dysfunction related to neurological impairment.
"Myrbetriq has been used to treat nearly 18 million adult patients worldwide with urological conditions"Treatment options for NDO have been limited or invasive, including scheduled toileting, catheterization, or surgery. If left untreated, NDO can lead to the deterioration of urinary tract function at an early age. Around 85% of children with NDO have spina bifida, a congenital spinal cord defect.
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