FDA Approves Mirabegron for Neurogenic Detrusor Overactivity in Pediatric Patients

 The Food and Drug Administration approved a new indication for mirabegron extended-release tablets (Myrbetriq; Silver Spring, MD) and mirabegron for extended-release oral suspension (Myrbetriq Granules; Silver Spring, MD) to treat neurogenic detrusor overactivity (NDO) in children age 3 years and more. 

"Today's action is a positive step for the treatment of NDO in young patients," said Christine P. Nguyen, MD, director, FDA's Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. "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." 

Improvements from mirabegron occurred for maximum bladder capacity, number of bladder wall muscle contractions, volume of urine held until first bladder wall muscle contraction, and number of daily urine leakage episodes after 24 weeks of treatment. 

The most common adverse events were constipation, headache, urinary tract infection, and nasopharyngitis