SMC approves Shire's Mezavant XL for UC

The Scottish Medicines Consortium has approved UK drugmaker Shire's Mezavant XL (prolonged-release mesalazine) 1,200mg for use within the National Health Service of Scotland for the induction of clinical and endoscopic remission in patients with mild-to-moderate active ulcerative colitis, as well as for maintenance of remission.

The agent, which is sold as Lialda in the USA, is part of a drug class called aminosalicylates, which are a well-established drug of choice and often a first-line treatment for UC. The therapy is the first new formulation in this class to be approved since 2000.

According to Shire, Mezavant XL has been shown to be effective in up to four out of 10 patients. In an eight-week Phase III, randomized, parallel-group, placebo-controlled trial, 40.5% of patients on 2.4g of Mezavant XL achieved clinical and endoscopic remission (p=0.007).