QLT

QLT USA, a subsidiary of Canadian biopharmaceutical firm QLT, says that the German regulatory authority has approved the six-month formulation of its anticancer drug, Eligard (leuprolide 45mg). The company added that the product, which is used as a palliative treatment for advanced prostate cancer, is already available in Germany and other European countries in both one- and three-month formulations.

QLT said that the drug, which is a luteinizing hormone-releasing hormone agonist, mediates its effect by lowering the level of testosterone in the body, which suppresses tumor growth in patients with prostate cancer. The company added that the agent is administered as a solid implant via subcutaneous injection, which releases leuprolide gradually over an extended period.

QLT explained that approval of the six-month formulation follows the submission of a Marketing Authorization Application to Germany's Federal Institute for Drugs and Medical Products, the BfArM, by Japan's Astellas Pharma, which licenses Eligard in Europe. The Vancouver-headquartered firm added that further European clearance for the drug is expected through the region's mutual recognition procedure.