Staines, 27th March 2012. ASTELLAS PHARMA EUROPE Ltd., the European subsidiary of Tokyo – based Astellas Pharma Inc.(Tokyo:4503) today announced the submission of a Market Authorisation Application for EC905 in the Netherlands. This application for approval is the first step of the European-wide mutual recognition process to authorise the drug in other EU countries. The submission was sent on 2nd March 2012.
EC905 is a combination tablet containing solifenacin 6 mg and tamsulosin OCAS 0.4 mg. Astellas is seeking approval for this new fixed dose combination therapy to treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia, with storage symptoms.
This announcement follows presentation of Phase III data on EC905 at the European Association of Urology annual congress in Paris on 26th February 2012. The data demonstrated that EC905 offered significant benefits over placebo, and was more effective than tamsulosin alone on storage parameters and quality of life in men with LUTS with voiding and storage symptoms aged 45 years and over.1
LUTS are common in men and include symptoms of voiding (e.g. hesitancy, intermittency), storage (frequency, urgency, nocturia) and post-micturition (feeling of incomplete bladder emptying).2 In a study of four European countries plus Canada,LUTS affected over 60% of the adult male population.3 Storage symptoms associated with LUTS are synonymous with overactive bladder syndrome, which can have a significant negative impact on quality of life, including work, social activities and sexual relationships.4
1. 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
2. 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
3. Irwin DE et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006;50:1306–15
4. Gomelsky A and Dmochowski RR. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-21