FDA Accepts sNDA for Mirabegron Combination Therapy

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB).

Produced by Astellas Pharma Inc, mirabegron (marketed as Myrbetriq) is already FDA approved as a monotherapy for OAB with symptoms of urgency and urinary frequency, and urge urinary continence. Solifenacin (VESIcare) is also approved for the same use.

"Living with overactive bladder can have a significant impact on even the simplest daily activities," Bernhardt Zeiher, MD, president of development at Astellas, said in a statement. "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."

The FDA’s decision to accept the combination therapy for review is based on data from 3, global phase 3 studies — SYNERGY I, SYNERGY II, and BESIDE – which examined more than 5000 patients with OAB and compared the combination therapy with each drug alone as well as placebo.

SYNGERY I compared the combination therapy to placebo and the monotherapy in 6991 patients with “wet” OAB for at least 3 months. SYNERGY II, a 52-week study, enrolled 2084 patients that had wet OAB for 3 months and compared mirabegron 50 mg and solifenacin succinate 5 mg in combination with each drug as a solo therapy.

The BESIDE trial registered 3815 OAB patients with inadequate response to treatment with solifenacin alone and compared the combination therapy to 5 mg and 10 mg doses of the solifenacin monotherapy.

OAB will reportedly affect an estimated 546 million people worldwide in 2018, according to data from a study published in 2011 by the University of North Carolina.

The anticipated Prescription Drug User Fee Act (PDUFA) date for the drug was set for April 28, 2018 by the FDA.

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