The applications follow the successful completion of a pivotal Phase III study, in which degarelix, a new GnRH receptor blocker, was studied for the speed of the suppression in levels of testosterone, the maintenance of the reduction during the one year study period as well as prostate-specific antigen (PSA) reduction.
Pascal Danglas, Ferring’s executive vice president of clinical and product development, said: “We believe that the data for degarelix is convincing and demonstrates the benefits that this drug can offer to patients suffering from the most common form of cancer in men. Subject to approval by regulatory bodies, we plan to start launching globally in 2009.”