Posted by Michael Wonder on 08 May 2018
FDA approves supplemental new drug application for Myrbetriq (mirabegron) for use in combination with solifenacin succinate for the treatment of overactive bladder symptoms
7 May 2018 - Astellas announced today that the U.S. FDA has approved a supplemental new drug application for the use of mirabegron in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder 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 overactive bladder.
The 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.
