The Scottish Medicines Consortium, Scotland’s equivalent to the National Institute for Health and Clinical Excellence in England and Wales, has decided to back the use of Astellas Pharma’s Vesicare (solifenacin) under the National Health Service in Scotland for the symptomatic treatment of overactive bladder syndrome.
The decision marks a major turnaround as the SMC originally rejected use of the agent last year on grounds that it felt it was too expensive and therefore uneconomical.
But results of the STAR study, which demonstrated that that the Vesicare works at least as well as the market-leader tolterodine in reducing the urge to urinate and it even superior in treating some of the symptoms associated with OAB, prompted a full resubmission to the SMC and its consequent endorsement of the product for NHS use.
Vesicare marks the first drug to be discovered and developed by Yamanouchi before its marriage to Fujisawa this year to create Astellas [[01/04/05c]], now the third-largest pharmaceutical group in Japan. Its first regulatory nod was received in The Netherlands in 2004 [[21/01/04b]], which was followed by a green light in the USA later that year [[23/11/04c]].
The drug is one of the leading growth drivers of Astellas’ turnover, and the group is expecting the drug to pull in sales of around 17 billion yen ($144.2 billion) for 2005, marking growth of 15% from the prior fiscal year [[19/05/05f]].