Today, the U.S. Food and Drug Administration approved a new brand for Myrbetriq (extended mirabegron tablets) and Myrbetriq Granules (mirabegron for oral contraceptives with extended release) to treat neurogenic hypertension (NDO), bladder dysfunction associated with neurological impairment, in children three years of age and older. Myrbetriq is also indicated for overactive bladder in adult patients.
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 with a different mode of action from the currently agreed therapies, providing a new treatment option for these young patients. We remain committed to enabling the development and approval of safe and effective treatments for pediatric NDO patients. “
Christine P. Nguyen, MD, Director, Department of Urology, Obstetrics and Gynecology at FDA, Office of Rare Diseases, Pediatrics, Urologic and Regenerative Medicine, Center for Drug Evaluation and Research
NDO is a disorder of the filter resulting from congenital conditions (inherited conditions beginning at or before birth), such as spina bifida, or other diseases or injuries of the nervous system, such as spinal injuries. With NDO, there is too much pressure in the bladder wall muscle, which usually rests to allow urine to be stored. Bladder wall muscle overactivity in NDO leads to shortening of the sporadic bladder muscle, which increases pressure in the bladder and reduces the amount of urine that the bladder can hold. . If NDO is not treated, excess pressure in the filter can put the upper urinary tract at risk of damage, including possible permanent damage to the kidneys. In addition, spontaneous bladder muscle shortening can lead to unexpected and frequent urination with signs of urinary urgency (need to urinate immediately), frequency (urinating more often than usual) and instability (loss of bladder control).
The efficacy of Myrbetriq and Myrbetriq Granules for the pediatric NDO symptom was established in a study of 86 patients aged 3 to 17 years. Improvements occurred in patients’ maximum cystometric (bladder) capacity, the number of complaints (bladder wall muscle), the volume of urine retained until the first rupture (bladder wall muscle) and the number of daily urine after 24 weeks of treatment.
The most common side effects of Myrbetriq and Myrbetriq Granules with NDO were urinary tract infection, nasopharyngitis (common cold), constipation and headache. Myrbetriq and Myrbetriq Granules can raise blood pressure and can worsen blood pressure in patients with a history of high blood pressure. Myrbetriq and Myrbetriq grains can 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 high airway inflammation occurs, as this may be life-threatening.
Myrbetriq and Myrbetriq Granules are two different products and cannot be replaced by milligram-per-milligram. The recommended dosage for Myrbetriq Granules for adults has not been confirmed.
Myrbetriq and Myrbetriq Granules have been licensed by the FDA to Astellas Pharma US, Inc.
Source:
U.S. Food and Drug Administration