NDA submitted for prostate cancer treatment

Ferring Pharmaceuticals has submitted applications in the United States and Europe for the marketing authorization of its prostate cancer treatment, degarelix, a new gonadotrophin-releasing hormone receptor blocker intended for patients in whom androgen deprivation is warranted.

The applications follow the successful completion of a pivotal phase III study in which degarelix was studied for the speed of the suppression in levels of testosterone, the maintenance of the reduction during the 1-year study period, and PSA reduction.

“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,” said Pascal Danglas MD, of Ferring. “Subject to approval by regulatory bodies, we plan to start launching globally in 2009.”