GSK receives European approval for Duodart®

• The first fixed dose combination medicine for benign prostatic hyperplasia

Issued: London UK

GlaxoSmithKline (GSK) today announced that Duodart^®, a fixed dose combination (FDC) of dutasteride (0.5mg), and tamsulosin (0.4mg) has received approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State. Duodart^® is indicated for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH¹.

“Recognising the benefits of these two medicines and the significant proven benefit of their dual use, GSK developed this new fixed dose combination medicine to provide patients and physicians a convenient, once daily treatment, which reduces the impact of the bothersome symptoms of this common condition, and the risk of potential complications and related surgery,” said Eddie Gray, President, Pharmaceuticals Europe, GSK. “These are the factors which create uncertainty and anxiety for many men and may also lead to additional unplanned costs for healthcare providers.”

The regulatory submission for dutasteride and tamsulosin FDC was based on data from the CombAT study*².

CombAT showed that the combination of dutasteride and tamsulosin offers patients with moderate-to-severe symptoms of BPH

• Significantly superior and sustained symptom improvement compared with the most frequently prescribed medication, the alpha blocker tamsulosin
• Symptom improvement that starts as rapidly as tamsulosin monotherapy and is sustained over 4 years
• A reduction in the risk of BPH complications – AUR and BPH related surgery vs tamsulosin by 66%** ( p<0.001) and="" by="" 20% vs dutasteride (p="ns)" monotherapy at 4>

* Bioequivalence has been demonstrated between the fixed dose combination and the free combination.

** Tamsulosin is not indicated to reduce the risk of AUR or BPH-related surgery.

The combination therapy was generally well-tolerated and most reported drug-related adverse events were as anticipated from the known safety profiles of the two drugs, with erectile dysfunction and ejaculatory disorders as the most commonly reported drug-related adverse events. There was no difference in overall cardiovascular events across treatment groups, although the incidence of cardiac failure observed was higher in the combination arm (0.9%) than in the tamsulosin arm (0.6%) and the dutasteride arm (0.2%).

No causal relationship between dutasteride (alone or in combination with an alpha-blocker) and cardiac failure has been established¹.

About European Decentralised Procedure

National licences are expected to be granted in the EU member states throughout 2010, with launches starting in the next few months.

About CombAT

The 4 Year Combination therapy with Avodart and Tamsulosin (CombAT) study was a multinational randomised study of 4,844 men, at increased risk of BPH progression, which investigated whether combination treatment with the 5-alpha reductase inhibitor (5ARI), dutasteride (0.5mg), and an alpha blocker, tamsulosin (0.4mg), was more effective than either monotherapy in improving symptoms and clinical outcomes in men with moderate-to-severe symptomatic BPH.

About BPH

BPH is a very common condition. The histological prevalence in the general male population is estimated to be over 50% of men aged 51-60 years, and increases to 90% in those aged 81-90³.The prevalence in Europe of moderate-to-severe symptoms of BPH in men ranges from 14% to 30%⁴.

For men who have moderate BPH, many experience the bothersome symptoms which impact their quality of life, including interrupted sleep due to nocturia, limitations on daily activities due to a frequent and urgent need to urinate, adverse impact on close relationships, anxiety, and fear of surgery ^5,6,7.

BPH is a progressive disease⁸ and can lead to serious complications like AUR and BPH related surgery ^5,9. BPH has a significant social and economic burden ^10,11,12.

Notes to Editors:

Duodart^® is a registered trade mark of the GlaxoSmithKline group of companies to be used in selected European markets pending local approvals.

Avodart^® is a registered trademark of the GlaxoSmithKline group of companies.

Combodart^® is a registered trade mark of the GlaxoSmithKline group of companies to be used in selected European markets pending local approvals.

References

1. Duodart Summary of Product Characteristics.

2. Roehrborn CG, Siami P, Barkin J,et al.The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study. Eur. Urol. 2010; 5 7:123-131.

3. Roehrborn CG et al. The Benign Prostatic Hyperplasia Registry and Patient Survey: study design, methods and patient baseline characteristics BJU Int 2007; 100: 813–9.

4. Madersbacher S et al. EAU 2004 Guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur. Urol. (2004); 46: 547-554.

5. Emberton M et al. Benign prostatic hyperplasia as a progressive disease: a guide to the risk factors and options for medical management. Int. J. Clin. Pract. 2008; 62: 18-26.

6. Garraway W et al. Impact of previously unrecognized benign prostatic hyperplasia on the daily activities of middle- aged and elderly men. British Journal of General Practice 1003, 318-321.

7. Mitropoulos D et al. Symptomatic Benign Prostate Hyperplasia: Impact on Partners’ Quality of Life Eur. Urol. 41(2002) 240-245.

8. Crawford ED et al. Baseline Factors as Predictors of Clinical Progression of Benign Prostatic Hyperplasia in Men Treated with Placebo. Journal of Urology 2006; 175, 1422-14.

9. Roehrborn CG. Acute Urinary Retention: Risks and Management. Med Reviews 2005; 7:31–41.

10. Fenter TC, Naslund MJ, Shah MB, et al. The Cost of Treating the 10 Most Prevalent Diseases in Men 50 Years of Age or Older Am J Manag Care 2006.

11. Black L, Naslund MJ, Gilbert TD, et al. An Examination of Treatment Patterns and Costs of Care Among Patients With Benign Prostatic Hyperplasia Am J Manag Care 2006;12:S99-S110.

12. McVary KT. BPH: Epidemiology and Co-morbidities. Am J of Managed Care 2006; 12 (5): 122-128.