FDA Approves mirabegron for Neurogenic Detrusor Overactivity in kids

"Today's action is a positive step for the treatment of NDO in young 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. "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."

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. Improvements occurred in patients' maximum cystometric (bladder) capacity, number of detrusor (bladder wall muscle) contractions, volume of urine held until first detrusor (bladder wall muscle) contraction and number of daily urine leakage episodes after 24 weeks of treatment.

The most common side effects with Myrbetriq and Myrbetriq Granules with NDO were urinary tract infection, nasopharyngitis (common cold), constipation and headache. Myrbetriq and Myrbetriq Granules may increase blood pressure and may make blood pressure worse in patients with a history of high blood pressure. Myrbetriq and Myrbetriq Granules may cause angioedema, an allergic reaction with swelling of the lips, face, tongue or throat. Patients should promptly discontinue Myrbetriq and Myrbetriq Granules and seek medical attention if angioedema associated with upper airway swelling occurs, as this may be life-threatening.

Myrbetriq and Myrbetriq Granules are two different products and they are not substitutable on a milligram-per-milligram basis. A recommended dosage for Myrbetriq Granules for adults has not been determined.