Netherlands first to approve Astellas' Vesomni
The European subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says that the Dutch Medicines Evaluation Board (MEB) has granted marketing authorization for Vesomni in the Netherlands, the first clearance for the drug, for treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) 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. Vesomni is a film-coated, bi-layered modified release tablet, for once-daily treatment. Each tablet contains 6mg of the antimuscarinic solifenacin and 0.4mg of the alpha1-adrenoceptor antagonist (α1-blocker) tamsulosin (in the oral controlled absorption system (OCAS; TOCAS).
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