GSK receives Swiss approval for Duodart
Switzerland's regulatory authority, Swissmedic, has approved Duodart®, a fixed-dose combination of dutasteride and tamsulosin. The medication is indicated for moderate-to-severe symptoms of benign prostatic hyperplasia (BPH).
GSK plc announced that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart®, a fixed-dose combination of dutasteride (0.5mg) and tamsulosin (0.4mg). This marks the first European approval for the medication, which is indicated for men with moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) and to reduce the risk of acute urinary retention (AUR) and surgery.
The approval in Switzerland is a significant milestone, and GSK anticipates further approvals and launches across Europe in 2010. The regulatory submission was supported by data from the CombAT study.
The CombAT study demonstrated that combination therapy with dutasteride and tamsulosin offered significant and sustained symptom improvement for men with moderate-to-severe BPH compared to tamsulosin monotherapy. The combination also significantly reduced the risk of BPH complications such as AUR and surgery.
Overall, the combination therapy was generally well-tolerated. While common drug-related adverse events included erectile dysfunction and retrograde ejaculation, the incidence of cardiac failure was slightly higher in the combination arm compared to monotherapy arms. No difference in overall cardiovascular events was observed across treatment groups.