Shire announced that Lialda (mesalamine delayed-release tablets) has been approved for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month, multicenter, randomized, double-blind, active comparator, non-inferiority study conducted in 826 adult patients in remission from ulcerative colitis. Of the patients receiving Lialda 2.4g/day (n=343) administered once daily, 83.7% maintained remission at Month 6, which was similar to that seen using the comparator, mesalamine delayed-release 1.6 g/day (n=336) administered as 0.8g given twice daily (81.5%, 95% CI for difference: -3.9%, 8.1%).
Lialda is already indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
For more information call (800) 828-2088 or visit www.lialda.com.