Vesomni (Astellas) approved in the Netherlands for Overactive Bladder

The Dutch Medicines Evaluation Board has granted marketing authorisation for Vesomni (solifenacin and tamsulosin), from Astellas, in the Netherlands for treatment of moderate to severe storage symptoms (Overactive Bladder, Urgency, increased micturition frequency) and voiding symptoms associated with Benign Prostatic Hyperplasia in men who are not adequately responding to treatment with monotherapy. The Netherlands will be the Reference Member State for further registration of Vesomni throughout Europe as part of future Mutual Recognition Procedures.

Approval is based on Phase III data which demonstrated that Vesomni offered statistically significant improvements vs. tamsulosin oral controlled absorption system (TOCAS) on storage parameters and quality of life in men with moderate to severe storage symptoms and voiding symptoms aged 45 years and over. In addition, Vesomni demonstrated statistically significant improvements vs. placebo over all key endpoints. In the Phase III study, the most frequently occurring adverse events for Vesomni were dry mouth and constipation, which were mostly mild in nature.