Posted by Michael Wonder on 12 Oct 2017
U.S. FDA accepts for review Astellas’ supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
12 September 2017 - If approved, the combination therapy could potentially offer a new treatment option for patients whose overactive bladder symptoms are not adequately controlled on monotherapy
Astellas announced today that the U.S. FDA has accepted for review a supplemental new drug application that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act goal date for a decision by the FDA is April 28, 2018. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq and VESIcare, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency.
The submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These studies, which included more than 5,000 patients with OAB, evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.
