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Ipsen has reported that the French Regulatory Authorities (AFSSAPS) have granted the marketing authorisation to the 6-month sustained-release formulation of Decapeptyl (triptorelin embonate1 22.5 mg) for the treatment of locally advanced and metastatic prostate cancer. The launch of the 6-month formulation of Decapeptyl in France by Ipsen should take place during the first semester of 2010.
Debiopharm has licensed the marketing rights to Ipsen for all territories where Ipsen currently commercialises triptorelin.
Ipsen and Debiopharm announced the successful completion of the European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands while for other European countries (Portugal, the UK, Ireland, Italy, Romania and Lithuania), the marketing authorisation applications were filed as a national line extension to the existing Decapeptyl’s ones. France is the first country to approve Decapeptyl 6-month in the context of the Decentralised procedure in Europe.
Decapeptyl is available in monthly or quarterly sustained-release formulations, as well as a daily formulation. Debiopharm developed and submitted the 1- and 3-month sustained release formulations of triptorelin embonate in Europe and the US.
The active substance in Decapeptyl is triptorelin, a decapeptide analogue of GnRH (Gonadotropin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotropins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testes and ovaries.
The product is marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, and uterine fibroids.
Etienne de Blois, deputy general manager for France operations of Ipsen, said: “Ipsen is pleased that the new 6-month formulation of Decapeptyl will be available for patients in France suffering from prostate cancer. Its improved convenience comes with a consistent and similar efficacy and tolerance to the already established Decapeptyl’s 1 and 3-month Decapeptyl formulations.”