Dutasteride - Glaxo Press Release
 

GlaxoSmithKline submits European Marketing Authorisation Application for dutasteride to treat BPH

London, October 4, 2001 - GlaxoSmithKline plc (GSK) today announces that it has submitted a European Marketing Authorisation Application (MAA) for dutasteride, a new treatment for Benign Prostatic Hyperplasia (BPH), to the Swedish Regulatory Authorities (MPA).

Clinical trials for dutasteride, involving over 4,300 patients suffering from BPH, have demonstrated that it provides long lasting symptom relief and positively impacts on disease progression.

Dutasteride is the first 5-alpha reductase enzyme inhibitor (5ARI) that inhibits both types 1 and 2 isoenzymes. These enzymes are responsible for converting testosterone to dihydrotestosterone (DHT) in the prostate, which are proven to play a key role in the development and progression of BPH.

BPH is a common benign growth in man and pathological changes of this disorder can be found in approximately 50% of men in their 50s and up to 90% of men in their 90s¹. BPH is defined as a non-cancerous enlargement of the prostate gland, which can lead to the manifestation of lower urinary tract symptoms (LUTS).

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 company information, visit GSK on the World Wide Web at http://www.gsk.com

Notes to the Editors:

Untreated BPH of long duration can give rise to a reduction in quality of life² and complications such as acute urinary retention (AUR) requiring hospitalisation, urinary tract infections, gross haematuria, bladder stones and rarely, renal failure. AUR is often considered by patients to be the most serious outcome of BPH and many symptomatic men are electing medical therapy in the hope of avoiding surgery.

The NDA for dutasteride was filed with the FDA in December 2000, using 1 year data, and the sNDA (full 2 year data) will be filed once approval for the NDA is obtained.

Current world-wide sales of treatments for BPH are £1,562 million, and in Europe are £574 million where annual growth is at a rate of +16%.

Several factors are expected to contribute to the expansion of this market including an ageing population and increased awareness/screening.

References:

¹ Berry SJ, Coffey DS, Walsh PC, and Ewing LL: The development of human benign prostatic ayperplasia with age. J Urol, 1984;132:474-479
² Natural History of prostatism: impact of urinary symptoms on quality of life in 2115 randomly selected community men. Girman C, Eptstein R, Jacobsen S, Guess H, Panser l, Osterling J, Lieber. Urology 44 (6): 825-831, 1994
 

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