TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration 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 or 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.
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.
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