Astellas receives Dutch approval for Vesmoni

Astellas has announced that the Dutch Medicines Evaluation Board has authorised its new drug Vesmoni for use as a treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).

The Netherlands has become the first country to approve the fixed-dose combination treatment – which includes solifenacin and tamsulosin in a single tablet – for the treatment of moderate to severe storage and voiding symptoms linked to the condition.

Phase III clinical trial data has shown that Vesmoni can offer statistically significant improvements and quality of life benefits for BPH patients who have not adequately responded to treatment with monotherapy.

The most frequently occurring adverse events associated with the drug were dry mouth and constipation, which were mostly mild in nature.

Following this decision, the Netherlands will be used as the reference member state for further registration of Vesmoni throughout Europe as part of future Mutual Recognition Procedures.

Earlier this month, Astellas allied with Drais Pharmaceuticals on the development of ASP7035, a promising new therapy for the treatment of nocturia.