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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)
Issued : Friday 19 December 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.
* Duodart® is a trade mark of the GlaxoSmithKline group of companies.
References
1. Roehrborn, C. G., Siami, P., Barkin, J. et al.: The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol, 179: 616, 2008
2. Debruyne, F., Barkin, J., van Erps, P. et al.: Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol, 46: 488, 2004
3. Lepor, H.: Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology, 51: 892, 1998
4. Narayan, P., Tewari, A.: A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol, 160: 1701, 1998
5. Roehrborn, C. G., Boyle, P., Nickel, J. C. et al.: Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology, 60: 434, 2002
6. Barkin, J., Haillot, O., Chantada, V. et al.: Improvements in patient-reported quality of life with dutasteride, tamsulosin and the combination: 2-year results from the Combination of Avodart and Tamsulosin (CombAT) trial. Abstract. Eur Urol Suppl, March, 2008
7. McVary, K. T.: BPH: epidemiology and comorbidities. Am J Manag Care, 12: S122, 2006
8. Roehrborn, C. G.: BPH progression: concept and key learning from MTOPS, ALTESS, COMBAT, and ALF- ONE. BJU Int, 101 Suppl 3: 17, 2008
9. Michel, M. C., Vrydag, W.: Alpha1-, alpha2- and beta-adrenoceptors in the urinary bladder, urethra and prostate. Br J Pharmacol, 147 Suppl 2: S88, 2006
10. Siami, P., Roehrborn, C. G., Barkin, J. et al.: Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. Contemp Clin Trials, 28: 770, 2007
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
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