FDA approves Myrbetriq (Astellas) for patients with Overactive Bladder

The FDA has approved Myrbetriq (mirabegron) extended-release tablets, from Astellas, for the treatment of Overactive Bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily. The approval of Myrbetriq was based on safety and efficacy data from three placebo-controlled Phase III studies, in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significant improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours. Myrbetriq is expected to be available in pharmacies in the fourth quarter of 2012. Mirabegron was approved in Japan in July 2011, and regulatory applications are under review in several other countries.