The approval covers a six-month sustained-release version of Decapeptyl®, an LHRH agonist.
Debiopharm and its European marketing partner, Ipsen, confirmed regulatory approval of its prostate cancer drug in nine European countries: Germany (the reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain, and The Netherlands. The sanction pertains to the six-month sustained-release formulation of Decapeptyl® and was given through the European decentralized procedure.
The companies say that the this new formulation will probably be launched first in Germany, The Netherlands, and Spain. The new sustained-release LHRH agonist is indicated for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer.
Decapeptyl® is already available in monthly or quarterly sustained-release formulations as well as a daily formulation. The drugs are marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, IVF applications, and uterine fibroids.