FDA Grants New Approval for Overactive Bladder Drug in Children

The FDA has granted a new indication to Astellas Pharma’s Myrbetriq and Myrbetriq Granules for treating neurogenic detrusor overactivity (NDO), a bladder dysfunction in pediatric patients age three and older.

The oral drug combination demonstrated efficacy in a trial involving 86 patients ages three to 17, with participants seeing improvements in their bladder capacity and the number of urine leakages following 24 weeks of treatment.

Myrbetriq was previously approved for treating overactive bladders in adults, but Myrbetriq Granules do not currently have a recommended adult dosage.