FDA approve Astellas’s Myrbetriq treatment for bladder dysfunction
The FDA have approved a new indication for Astellas Pharma’s Myrbetriq and Myrbetriq Granules to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment in children aged three years and older.
NDO leads to an overactivity of the bladder wall muscle, which can result in a decrease in the volume of urine the bladder can hold and ultimately permanent damage to the kidneys. The spontaneous contractions it causes can also lead to other symptoms including incontinence.
The efficacy of Myrbetriq and Myrbetriq Granules for children with NDO was established in a study of 86 patients aged 3 to 17 years old. Improvements occurred in patients’ maximum bladder capacity, number of bladder wall muscle contractions, volume of urine held until first contraction, and number of daily urine leakage episodes after 24 weeks of treatment.
The most common side effects of the treatment were urinary tract infection, common cold, constipation and headache.
Myrbetriq has also been indicated for an overactive bladder in adult patients, while a recommended dosage for Myrbetriq Granules for adults has not yet been determined.
Dr Christine P Nguyen, Director of the FDA’s Division of Urology, Obstetrics and Gynaecology, Office of Rare Diseases, Paediatrics, Urologic and Reproductive Medicine, said: “Today’s action is a positive step for the treatment of NDO in young patients.
“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 paediatric NDO patients.”
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