Company submits new drug application for OAB therapy

Astellas Pharma Inc. has announced the submission of a new drug application and market authorization application for mirabegron, a once-daily oral selective beta3-adrenoceptor agonist, to the FDA and the European Medicines Agency.

Astellas is seeking approval for mirabegron for the indication of overactive bladder associated with symptoms of urgency, urinary frequency, and urge urinary incontinence.

Phase III clinical trials in the United States and Europe met primary endpoints compared with placebo, according to the company. Look for an article discussing findings from a pivotal U.S. trial in the October issue of Urology Times.