Ferring Pharmaceuticals of the US has received Food and Drug Administration approval for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer.
Ferring said the trade name for the drug is still under review with the FDA. Once a trade name is issued Ferring will immediately begin commercialization in the US.
"Degarelix was discovered in San Diego, developed by Ferring Pharmaceuticals in the US and Europe, and in its pivotal phase III study demonstrated both an immediate onset of action and a profound long-term suppression of testosterone and PSA," said Dr. Pascal Danglas, Executive Vice President Clinical & Product Development, at Ferring. "We are delighted to deliver a new treatment option for advanced prostate cancer to the medical community. Ferring has a considerable pipeline of urology products in development, and we expect to introduce additional treatment advances in the urology field in the near future."
Wayne Anderson, President and CEO Ferring Pharmaceuticals said, "We are enthusiastically preparing to enter this therapeutic area of urology. We respect the challenges physicians and patients face in their fight against prostate cancer and hope that we can help them with this new treatment option. This is a big milestone for the US operating unit, and we have been carefully preparing for over two years for this launch”.