Eligard six-month formulation successfully completes European approval procedure
QLT USA, Inc., a subsidiary of QLT Inc., announced that the European approval procedure for the Eligard(R) 45 mg six-month formulation was successfully completed. Launch of this formulation in 23 European countries is expected to follow the implementation of this positive decision in each of the individual countries. The 6-month formulation was launched in Germany in March 2007 following its approval in December 2006. Eligard is already approved in Germany and other European countries for the one-month (7.5 mg) and three-month (22.5 mg) formulations.
Eligard, a palliative treatment for advanced prostate cancer, incorporates a luteinizing hormone-releasing hormone agonist, or LHRH agonist, known as leuprolide acetate with QLT USA's proprietary Atrigel(R) Delivery System. The Atrigel technology allows for sustained delivery of leuprolide acetate for periods ranging from one to six months.
Eligard works by lowering the levels of testosterone in the body, which may result in a reduction of symptoms related to the disease. Sustained levels of leuprolide decrease testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The liquid Eligard products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.
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