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Astellas Receives Marketing Authorisation For Vesomnitm From The Netherlands Medicines Evaluation Board

first to approve new fixed-dose combination treatment for men with associated with BPH

ASTELLAS PHARMA EUROPE B.V., the European subsidiary of Tokyo-based (Tokyo:4503), have announced the (MEB) has granted marketing authorisation for in the Netherlands.

The market authorisation granted for VESOMNI is for “treatment of moderate to severe symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy”.1

The Netherlands will be the Reference Member State for further registration of VESOMNI throughout Europe as part of future Mutual Recognition Procedures. VESOMNI is a film-coated, bi-layered modified release tablet, for once-daily treatment. Each tablet contains 6 mg of the antimuscarinic solifenacin and 0.4 mg of the alpha1-adrenoceptor antagonist (α1-blocker) tamsulosin (in the oral controlled absorption system [OCASTM]) (TOCAS).

Phase III data demonstrated that VESOMNI offered statistically significant improvements vs. TOCAS on storage parameters and quality of life in men with moderate to severe storage symptoms and voiding symptoms aged 45 years and over.2 In addition, VESOMNI demonstrated statistically significant improvements vs. placebo over all key endpoints.2

In the Phase III study, the most frequently occurring adverse events for VESOMNI were dry mouth and constipation, which were mostly mild in nature.2

About LUTS / BPH

Lower urinary tract symptoms (LUTS) associated with BPH are common in men and can include storage symptoms (frequency, urgency, nocturia) and/ or voiding (e.g. hesitancy, intermittency).3

In a study of 14,139 men aged 40 years and over, 71% reported at least one LUTS.4 49% of the men with LUTS reported both storage and voiding symptoms.4 α-blockers are currently first-line treatment for voiding symptoms in men with LUTS/BPH but often do not adequately relieve storage symptoms.5 Storage symptoms are the most bothersome to the patient4 and can have a significant impact on quality of life.6 1. Data on file

2. Drake M et al. Efficacy of combination therapy with tamsulosin OCAS and solifenacin in NEPTUNE: Results from a randomized Phase III trial in men with LUTS. EAU 2012 Poster AM12-2045

3. Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: 167-78

4. Sexton CC et al. The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS. BJU Int 2009;103(Suppl.3):12-23

5. Guidelines on the Treatment of non-neurogenic male LUTS

6. Milsom I. et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001; 87(9): 760-766


Source: Astellas Pharma Europe Ltd.