Policy & Regulation
Astellas Pharma files sNDA with the US FDA for mirabegron combined with solifenacin succinate to treat overactive bladder
13 September 2017 -

Pharmaceutical company Astellas Pharma Inc (TSE:4503) stated on Tuesday that it has submitted its supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for review for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB).

The company added the anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the US FDA is 28 April 2018.

According to the company, the mirabegron and solifenacin succinate are marketed in the US as Myrbetriq and VESIcare, respectively. Each is approved by the US FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency.

Overactive bladder is reportedly a urine storage problem of urgency, with or without urge urinary incontinence (leakage), often with urinary frequency and nocturia.

This sNDA submission is based on data from the company's 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.

Concurrently, the company's Phase 3 SYNERGY I trial evaluated the efficacy and safety of combinations of mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo in OAB patients.The 52-week, Phase 3 SYNERGY II trial evaluated the efficacy and safety of combination of mirabegron 50 mg and solifenacin succinate 5 mg compared with each drug as monotherapy in OAB patients. The Phase 3b BESIDE study 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.

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