Myrbetriq Receives New Pediatric Indication

March 25, 2021 – The U.S. FDA has approved a new indication for Astellas Pharma’s Myrbetriq® (mirabegron extended-release tablets) and Myrbetriq® Granules (mirabegron for extended-release oral suspension). The products are now indicated to treat neurogenic detrusor overactivity (NDO) in children who are at least three years of age.

NDO is a type of bladder dysfunction that occurs in patients who have neurological impairment. The impairment may occur due to an inherited condition, such as spina bifida, or other disease or injury affecting the nervous system, such as spinal cord injuries. In the absence of proper communication from the nervous system, the bladder wall muscle contracts in a sporadic fashion. This increases pressure on the bladder, reduces the bladder volume available to hold urine, and causes urinary incontinence. It can also cause harm to the upper urinary tract that includes permanent kidney damage.

In a clinical study, patients 3-17 years old who received Myrbetriq saw improvement in maximum bladder capacity, number of bladder wall muscle contractions, volume of urine held until first contraction, and number of daily urine leakage episodes.

Recommended dosing under the new indication is based on weight and requires use of a starting dose for four to eight weeks before transitioning the patient to a maintenance dose . Myrbetriq and Myrbetriq Granules are taken by mouth once daily for NDO, with the granules mixed in 100mL of water to create an oral suspension. For pediatric patients who weigh less than 35kg (77 pounds), treatment with Myrbetriq Granules rather than the tablet form is recommended. Pediatric patients weighing 35kg or more may be treated with either the tablet or granule dosage form.

First FDA approved in 2012, Myrbetriq is also indicated for use alone or with solifenacin succinate to treat overactive bladder in adults who experience symptoms of urge urinary incontinence, urgency, and urinary frequency.