Shire has moved a step closer to getting marketing approval for its ulcerative colitis treatment Mezavant, after the company revealed it has agreed labelling information with European regulators.
The firm noted that core labelling for Mezavant (mesalazine) has been agreed by the regulatory agencies for the 15 European countries participating in the decentralised procedure. Once that procedure is completed, “associated national approvals should follow in the first quarter of 2007,” enabling Shire to make a phased launch of the product across Europe.
The 1200mg tablet will be indicated both for the induction of clinical and endoscopic remission in patients with mild-to-moderate, active ulcerative colitis and for maintenance of remission.
This formulation of mesalazine uses a drug delivery technology developed by Italian firm Cosmo, called MMX, which is designed to allow astro-resistant, prolonged release of the drug throughout the colon in a once-daily dose. Shire licensed Mezavant from another Italian company, Giuliani, in 2002, and holds rights to the compound in the USA, Canada, Europe (excluding Italy) and the Pacific Rim.
Shire filed for approval of Mezavant in the USA in December 2005, and the Food and Drug Administration is scheduled to review it on January 21.