Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) has obtained marketing approval for its overactive bladder treatment Vesicare (YM905) with the indication of urinary frequency, urgency, and urge incontinence associated with overactive bladder (OAB*). An application for approval was submitted in August 2004.
OAB is caused by excessive contraction of smooth muscles of the urinary bladder and is associated with symptoms such as urinary frequency, urgency, and urge incontinence. In Japan, the number of OAB patients is estimated to be about 8.1 million, nearly 12% of men and women aged 40 years or older. These symptoms caused significant inconvenience and distress in patient's activities of daily living.
Discovered and developed by Astellas, Vesicare is the first drug approved for OAB in Japan. It relaxes bladder smooth muscles and improves symptoms associated with OAB such as urinary frequency, urinary incontinence and urgency by blocking muscarinic receptors of the bladder smooth muscle. This drug has already been marketed in around 20 countries in Europe and the US as Astellas' global strategic product contributing to the improvement of QOL of patients troubled by symptoms of OAB. Astellas is confident that Vesicare will also contribute to the QOL of patients in Japan as a new treatment option of OAB. Astellas will launch it onto the market as soon as it is listed in the NHI drug price list.
Details of approval are as follows:
|Date of marketing approval||April 20, 2006|
|Brand name||Vesicare® tablet 2.5mg and 5 mg|
|Generic name||solifenacin succinate|
|Classification||therapeutic agent for overactive bladder|
|Indication||urinary frequency, urgency, and urge incontinence associated with overactive bladder|
|Approval holder||Astellas Pharma Inc.|
* OAB: overactive bladder