FDA Approves Supplemental New Drug Application for Myrbetriq^® (mirabegron) for Use in Combination with solifenacin succinate for the Treatment of Overactive Bladder Symptoms

TOKYO, May 7, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of mirabegron in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
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 OAB.
“OAB patients may have symptoms that are not fully managed with their current treatment," said Carol Schermer, M.D., M.P.H., senior medical director, urology, Astellas. "With the FDA approval of Myrbetriq in combination with solifenacin succinate, Astellas is able to offer an additional treatment option to individuals living with symptoms of OAB."
The sNDA submission was based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These studies evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy or placebo.