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| GSK files for European Marketing Authorisation of Duodart® for benign prostatic hyperplasia
GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) in Europe for Duodart® (dutasteride 500 micrograms and tamsulosin HCI 400 micrograms) | |||
| 19 Dec 2008
, London, UK
: GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) in Europe for Duodart® (dutasteride 500 micrograms and tamsulosin HCI 400 micrograms) for the treatment of men with moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery, in men with moderate-to-severe symptoms of BPH. Once approved, Duodart® would be the first fixed-dose combination therapy for the treatment of BPH,providing better efficacy than either monotherapy. 1 The application has been filed in 28 European countries via the Decentralised Procedure with Germany acting as ReferenceMemberState. “BPH is a widespread condition that continues to pose a considerable heath problem to ageing men through both its symptoms and potential associated complications. GSK’s goal is to advance prostate health care by providing treatments that improve these symptoms and mens’ quality of life”, said Ramiro Castro, MD, Medical Director, Urology Centre of Excellence, GSK. Data have shown that the combination of dutasteride and tamsulosin can provide an effective treatment for BPH, combining the advantages of both classes of drug: dutasteride, a dual 5α-reductase inhibitor (5ARI), and tamsulosin, an α–blocker. The combination can provide men with the rapid symptom relief of an α–blockerand long-term sustained symptom reduction, as well as the benefits of reduction in the risk of long-term complications such as the risk of AUR and BPH-related surgery, of a dual 5ARI2-5. This MAA file is based on positive 2 year results results from the Combination of Avodart® and Tamsulosin (CombAT) study, and studies showing bioequivalence between combination and fixed-dose combination. CombAT is a randomised controlled trial in more than 4,800 patients, which showed that combination therapy with dutasteride and tamsulosin provided significantly superior and sustained improvements over two years in symptoms, peak urinary flow (Qmax)and BPH-related quality-of-life versus either monotherapy, in men with moderate-to-severe BPH symptoms 1, 6. The combination of dutasteride and tamsulosin has been shown to provide significantly superior and sustained improvements in men’s BPH symptoms versus dutasteride alone from month 3 onwards and versus tamsulosin alone from month 9 onwards1. The safety profile associated with combination therapy over a two-year period was consistent with that reported for either monotherapy. Although treatment-related adverse events (AEs) (mainly sexually related) were more common with the fixed-dose combination, withdrawal rates due to AEs were low (≤5%) across all treatment groups.1 About BPH BPH is one of the most common health problems in ageing men. More than 1 in 4 men in their 50s and nearly half of all men in their 80s suffer from moderate-to-severe lower urinary tract symptoms (LUTS). LUTS, such as weak urinary stream, frequency, nocturia, and urge incontinence, interfere with usual daily activities and have a negative impact on patients´ quality of life. Symptoms may worsen over time and there is a risk of acute urinary retention (AUR) and the need for BPH-related surgery.7, 8 About Dutasteride Dutasteride is the only BPH treatment that inhibits both type 1 and type 2 5α-reductase isoenzymes, blocking the conversion of testosterone into the primary male hormone, dihydrotestosterone (responsible for prostate growth and BPH development), providing long-term symptom improvement, and reducing the risk of BPH complications (AUR and surgery) 2, 5. About Tamsulosin Tamsulosin is a widely prescribed α-blocker, which provides a rapid onset of urinary symptom relief, primarily by reducing the smooth muscle tone in the prostate and bladder neck 3, 4, 9. About CombAT study The CombAT (Combination of Avodart®and Tamsulosin) trial is an ongoing four year, randomised, double-blind, multicentre (446 investigators in 35 countries), parallel group study investigating the efficacy and safety of the dual 5α-reductase inhibitordutasteride (0.5mg), and the a-blockertamsulosin(0.4 mg), separately and in combination, in 4,844 men with moderate-to-severe BPH symptoms (IPSS ≥ 12), a prostate volume ≥ 30 cc and serum PSA ≥1.5 ng/mL. The two-year CombAT results demonstrated that the combination therapy provided significantly superior and sustained improvement in symptoms, urinary flow and BPH-related quality of life than either monotherapy over 2 years 1, 6. The CombAT study, still ongoing, will also evaluate, at four years, the efficacy of dutasteride and tamsulosin combination therapy versus each monotherapy alone in reducing the risk of AUR and BPH-related surgery 10. GSK is one of the world’s leading research-based pharmaceutical and healthcare companies. GSK is committed to researching and developing treatments for urological conditions to enable healthcare professionals to meet the needs of patients. GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com. |
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