FDA Approves Once-Daily Mesalamine for Ulcerative Colitis

Shire received approval from the FDA for Lialda (mesalamine) with MMX technology, indicated for patients with active mild-to-moderate ulcerative colitis. Lialda is the only FDA-approved once-daily oral formulation of mesalamine. Shire will launch the drug in the U.S. in 1Q2007.

Other currently available mesalamines require three to four doses daily of 6 to 16 pills. A recent study conducted by the Crohn’s and Colitis Foundation of America (CCFA) found that 65% of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.

The FDA approval was based on the results of two Phase III studies that found Lialda (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment. Lialda is generally well tolerated and has a similar safety profile to other currently available mesalamines.