ASTELLAS PHARMA EUROPE Ltd., the European subsidiary of Tokyo - based Astellas
Pharma Inc. 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.
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). In a study of four European countries plus Canada, LUTS affected over 60% of the adult male population. 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.
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