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FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms

TOKYO, May 7, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) 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 (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.1

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.1,2

"OAB patients may have symptoms that are not fully managed with their current treatment," said Carol Schermer, M.D., M.P.H., senior medical director, urology, Astellas. "With the FDA approval of Myrbetriq in combination with solifenacin succinate, Astellas is able to offer an additional treatment option to individuals living with symptoms of 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.3,4,5>/sup>

About the SYNERGY I Trial

The Phase 3 SYNERGY I trial enrolled 6,991 patients across 435 study locations in 42 countries.3 The trial evaluated the safety profile 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.4 The trial evaluated the long term safety profile 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 2,174 patients across 281 sites in 31 countries.5 The trial evaluated the efficacy, safety and tolerability of mirabegron 50 mg as an add-on therapy with solifenacin succinate 5 mg versus solifenacin succinate 5 mg and 10mg alone in OAB patients who had inadequate response to treatment with solifenacin succinate monotherapy.

About Overactive Bladder (OAB)

Overactive bladder is a urine storage problem of urgency, with or without urge urinary incontinence (leakage), often with urinary frequency and nocturia.6 It has been estimated by this year, 546 million people worldwide will be affected by OAB.7 For people with OAB, inappropriate signals are sent to the muscles in the bladder causing them to contract before the bladder is full.8 These bladder contractions may cause strong, sudden urges, and a frequent need to go to the bathroom.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.


  1. Myrbetriq [package insert]. Northbrook, IL; Astellas, Inc.
  2. VESIcare [package insert]. Northbrook, IL: Astellas, Inc.
  3. Herschorn S, Chapple CR, Abrams P, et al. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU Int 2017;120(4):562-75.
  4. A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder (09-21-2017). Accessed 02-22-2018.
  5. Drake MJ, Chapple C, Esen AA, et al. Efficacy and safety of mirabegron add-on therapy to solifenacin in incontinent overactive bladder patients with an inadequate response to initial 4-week solifenacin monotherapy: a randomised double-blind multicentre phase 3B study (BESIDE). Eur Urol 2016;70(1):136-45.
  6. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 2003;61(1):37-49.
  7. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011;108(7):1132-8.
  8. Sadananda P, Drake MJ, Paton JFR, Pickering AE. A functional analysis of the influence of β3-adrenoceptors on the rat micturition cycle. J Pharmacol Exp Ther 2013;347(2):506-15.

SOURCE Astellas Pharma Inc.

Posted: May 2018

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