Potential trade names are still under review with the FDA. Following issuance of a trade name, Ferring Pharmaceuticals, USA is expected to immediately begin commercialization in the US.
Previously, the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, recommended granting a marketing authorization for degarelix in Europe. Degarelix is awaiting approval in other key global markets.
Pascal Danglas, executive vice president of clinical and product development, at Ferring, said: 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 prostate specific antigen.
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.
Ferring Pharmaceuticals and Conaris Research have entered into a worldwide license agreement for the development of FE301 a new recombinant protein inhibitor for inflammatory conditions such as IBD and rheumatoid arthritis.