GlaxoSmithKline’s (GSK) benign prostatic hyperplasia (BPH) treatment, Duodart®, received European regulatory clearance via the decentralized procedure. The once-daily drug comprises a fixed-dose combination of dutasteride and tamsulosin. It is indicated for treating moderate-to-severe symptoms of BPH and reducing the risk of acute urinary retension and surgery in relevant patients.
Germany is acting as the Reference Member State for pan-European clearance. GSK expects national licenses to be granted in EU member states during the course of this year, with the first launches due in the next few months.
European approval for Duodart was based on data from the CombAT trial, which showed that treatment using the dutasteride-tamsulosin combination provided patients with significantly better and more long-lasting symptom improvements in comparison with tamsulosin monotherapy. Duodart also reduced the risk of BPH complications by 66% in comparison with tamsulosin alone and by 20% compared with dutasteride monotherapy.