Shire targets Q1 07 EU launch of Mezavant

UK drugmaker Shire says that core labeling information, which is part of the Marketing Authorization Application for its ulcerative colitis drug Mezavant (mesalazine), has been agreed by the regulatory agencies for the 15 European countries (including the UK, Germany, France and Spain) participating in the decentralized procedure. Following closure, associated national approvals should follow in the first quarter of 2007, enabling Shire to make a phased launch of the agent in Europe.

Mezavant is the only UC treatment that utilizes novel MMX Multi Matrix drug-delivery technology to provide gastro-resistant, prolonged release of mesalazine throughout the colon in a once-daily dose. Available as a tablet containing 1,200mg mesalazine, the agent will be indicated both for induction of clinical and endoscopic remission in patients with mild-to-moderate active UC, and for maintenance of remission. A US New Drug Application has been submitted to the Food and Drug Administration and has a January 21, 2007, action date.