Astellas Pharma Inc. (ALPMY) recently announced the receipt of marketing authorization for Vesomni in the Netherlands. Vesomni is approved as a fixed dose combination therapy to treat moderate to severe storage and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men.
These patients have not adequately responded to monotherapy treatment. For further registration of Vesomni throughout Europe, the Netherlands will be the Reference Member State.
The approval was based on phase III data which showed Vesomni offered statistically significant improvements as compared to tamsulosin (in the oral controlled absorption system) (TOCAS) on storage parameters and quality of life in men (aged 45 years and above) with moderate to severe storage symptoms and voiding symptoms.
In all important endpoints, Vesomni demonstrated statistically significant improvements versus placebo. The adverse events in the study included dry mouth and constipation.
Lower urinary tract symptoms (LUTS) associated with BPH is common in men. As per information provided by Astellas Pharma, a study has demonstrated that 71% of men have at least one LUTS and 49% of the men with LUTS have shown both storage and voiding symptoms.
The BPH market offers significant commercial potential and currently approved drug includes GlaxoSmithKline plc’s (GSK) Avodart. Avodart sales amounted to £203 million in the said quarter, reflecting an increase of 10% year over year.
Astellas Pharma currently carries a Zacks Rank #4 (Sell). Currently, companies like Santarus, Inc. (SNTS) and Salix Pharmaceuticals Ltd. (SLXP) look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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