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news.Astellas Pharma has filed a market authorisation application (MAA) for one month formulation of Degarelix acetate (degarelix; generic name; development code: ASP3550) to the Ministry of Health, Labour and Welfare (MHLW) in Japan, for the indication of prostate cancer.
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Degarelix is a gonadtrophin-releasing hormone (GnRH) blocker with a subcutaneously injectable formulation.
In January 2006, Astellas and Ferring International Center entered into a license agreement that gives Astellas exclusive rights to develop and market degarelix for the treatment of prostate cancer in Japan.
Since then, Astellas has conducted the development of degarelix in Japan from Phase II.
The Phase II study demonstrated the maintenance of blood testosterone below castration level for one year. Also, based on the safety results, degarelix appears to be safe and well tolerated.
Based on the results of Phase-I and Phase-II studies in Japan, Astellas decided to submit this MAA by using abroad Phase-III data, skipping Phase III study in Japan.
Degarelix was approved for the treatment of prostate cancer by the US Food and Drug Administration in December 2008 and by the European Medicines Agency in February 2009, and is commercialised in 21 countries including US, Canada, UK, Germany and France.
Astellas expects to provide an additional therapeutic option, and further contribute to the treatment of prostate cancer by introducing Degarelix with a new mechanism of action, into the Japanese market.