Astellas Submits a New Drug Application for Gonax® 12-Week Extended-Release Formulation for Treatment of Prostate Cancer in Japan (pdf 249KB)

On November 30, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that that it submitted an application for marketing approval in Japan of GnRH antagonist, Gonax (development code: ASP3550; generic name: degarelix acetate) 12-week extended-release formulation for treatment of prostate cancer (Press release, Astellas, NOV 30, 2017, View Source [SID1234522307]).

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Gonax became available in 4-week extended-release formulation with the indication of prostate cancer in October 2012 in Japan. The 12-week extended-release formulation is expected to improve convenience of use and increase adherence for patients.

Astellas sets that Oncology is one of focused disease areas for research and development, and expects that Gonax 12-week extended-release formulation will further expand the treatment choices available for patients with prostate cancer.

Submission of the application for marketing approval has no impact on the financial results for the fiscal year 2017 ending March 31, 2018.

About Gonax
Gonax is a gonadtrophin-releasing hormone (GnRH) antagonis with a subcutaneously injectable formulation. Astellas acquired exclusive development and commercialization rights of Gonax for the use of prostate cancer treatment in Japan from Ferring International Center SA* in January 2006. GnRH is a hormone synthesized and released from the hypothalamus in the brain and is involved in the production of the male hormone testosterone thorough binding to the GnRH receptors in the pituitary gland. Although testosterone is an important hormone that plays a central role in the maintenance of male function, it also stimulates prostate cancer to grow and to spread out and in result, often aggravates symptoms in prostate cancer patients. Gonax competitively inhibits the binding of GnRH to the GnRH receptors and controls the growth of prostate cancer by suppressing the testosterone.

*All rights and obligations under the agreement were assigned by Ferring International Center SA to Ferring Private Ltd. in January 2016.