(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said Friday that the U.S. Food and Drug Administration approved Myrbetriq (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for the treatment of neurogenic detrusor overactivity or NDO in pediatric patients aged three years and older.
The FDA also granted pediatric exclusivity for Myrbetriq, resulting in an additional six month period of market exclusivity.
Neurogenic detrusor overactivity is a type of bladder dysfunction caused by nerve damage and is marked by uncontrolled bladder contractions that can lead to symptoms of urinary frequency, urgency and incontinence. Eighty-five percent of children with NDO have spina bifida, a congenital spinal cord defect.
Myrbetriq tablets are currently available in the U.S. Myrbetriq Granules were developed for ease of administration in younger children with NDO, or children with NDO who may have difficulty swallowing tablets, and will be available in the U.S. by the end of 2021.
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