Shire's Lialda cleared by US FDA

Basingstoke, UK-based drugmaker Shire says that the US Food and Drug Administration has approved Lialda (mesalamine) with MMX technology, indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. The agent is the first and only FDA-approved once-daily oral formulation of mesalamine, which is part of the aminosalicylate class of drugs. Shire plans to launch Lialda in the USA in the first quarter of the year. The agent contains the highest mesalamine dose per tablet (1.2g), so patients can take as few as two tablets once daily. Other currently-available mesalamines require three to four times daily dosing and six to 16 pills a day, Shire noted, adding that a recent study found that 65% of UC patients are poorly compliant with their medication, citing pill burden and inconvenience of taking their medication.