GlaxoSmithKline plc (GSK) has received European approvals, for Avodart (dutasteride), a new treatment for benign prostatic hyperplasia (BPH). Major European countries have approved an indication for the use of Avodart in the treatment of moderate to severe symptoms of BPH and for the reduction in risk of acute urinary retention (AUR) and surgery, in patients with BPH. Following review under the Mutual Recognition Procedure (MRP), these approvals come 90 days after dutasteride was first approved by the Reference Member State Sweden; (in Sweden dutasteride has been approved with the trade name Avolve). GSK plan to market Avodart in all major European markets with launches in the first half of 2003.
Commenting on the approval, Professor Roger Kirby, Professor of Urology, St George's Hospital, London said: "Avodart provides BPH patients and their doctors with a new long-term treatment option. In clinical trials involving in excess of 4,300 patients with BPH over two years, Avodart provided long lasting symptom improvement and reduced the risk of AUR - the sudden complete inability to urinate - by 57 per cent, and the need for BPH-related surgery by 48 per cent."
Avodart is the first and only 5-alpha reductase inhibitor (5ARI) that inhibits both the type 1 and 2 isoenzymes of 5-alpha reductase, the enzyme responsible for converting testosterone to dihydrotestosterone (DHT) in the prostate and other tissues. DHT is the primary cause of prostate growth that has been proven to play a key role in the development and progression of BPH. Avodart decreases levels of DHT by 90 per cent and this is maintained at two years.
BPH is a common benign growth in ageing men. It is this non-cancerous enlargement of the prostate gland that frequently causes lower urinary tract symptoms (LUTS). BPH is a progressive disease and if left untreated for a long duration, can in severe cases result in complications such as AUR and surgery requiring hospitalisation.
Overall, in clinical trials, the most commonly reported adverse events as reported in the approved Summary of Product Characteristics were impotence (6%), altered / decreased libido (3.7%), ejaculation disorder (1.8%), gynaecomastia (1.3%).
Avodart was developed by GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.