pharmaceutical daily

FDA approves new indication for Astellas Pharma’s bladder dysfunction drug

The U.S. Food and Drug Administration approved a new indication for  Astellas Pharma’s  Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.
NDO is a dysfunction of the bladder that results from congenital conditions (inherited conditions beginning at or before birth), such as spina bifida, or other disease or injury in the nervous system, such as spinal cord injury.
“Mirabegron, the active ingredient in Myrbetriq and Myrbetriq Granules, works by a different mechanism of action from the currently approved treatments, providing a new treatment option for these young patients. We remain committed to facilitating the development and approval of safe and effective therapies for pediatric NDO patients.” said Christine P. Nguyen, M.D., director, FDA’s Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research.
FDA said that the efficacy of Myrbetriq and Myrbetriq Granules for the pediatric NDO indication was established in a study of 86 patients ages 3 to 17 years old.
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