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.
The U.S. Food and Drug Administration (FDA) has accepted for review Astellas Pharma Inc.’s supplemental New Drug Application (sNDA) 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 (PDUFA) 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 sNDA 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.
“Living with overactive bladder can have a significant impact on even the simplest daily activities,” said Bernhardt Zeiher, M.D., president of Development at Astellas. “Acceptance of this sNDA is an important step forward in bringing a potential new treatment option to individuals living with OAB whose symptoms may not be controlled on monotherapy.”
About the SYNERGY I Trial
The Phase 3 SYNERGY I trial enrolled 6.991 patients across 435 study locations in 42 countries. The trial evaluated the efficacy and safety of combinations of mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo in patients who had experienced symptoms of “wet” OAB (urinary frequency and urgency with incontinence) for at least 3 months.
About the SYNERGY II Trial
The 52-week, Phase 3 SYNERGY II trial enrolled 2,084 patients across 251 sites in 32 countries. The trial evaluated the efficacy and safety of combination of mirabegron 50 mg and solifenacin succinate 5 mg compared with each drug as monotherapy in patients who had experienced symptoms of “wet” OAB (urinary frequency and urgency with incontinence) for at least 3 months.
About the BESIDE Trial
The Phase 3b BESIDE study enrolled 3,815 patients across 281 sites in 36 countries. The trial evaluated the efficacy, safety and tolerability of mirabegron 50 mg in combination with solifenacin succinate 5 mg versus solifenacin 5mg and 10mg alone in OAB patients who had inadequate response to treatment with solifenacin succinate monotherapy.
Use of Myrbetriq
Myrbetriq (mirabegron) is a prescription medicine for adults used to treat OAB with symptoms of urgency, frequency and leakage.
(Source: PR Newswire)
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