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news.Shire has said that the FDA has approved Lialda with MMX technology indicated for the induction of remission in patients with ulcerative colitis.
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Lialda is the first and only FDA-approved once-daily oral formulation of mesalamine. Shire will launch Lialda in the US in the first quarter of 2007.
Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet, 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.
A recent study conducted by the Crohn's and Colitis Foundation of America 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 was effective in inducing remission in patients with 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.
Shire has licensed from Giuliani the exclusive rights to develop and commercialize Lialda in the US, Canada, Europe and the Pacific Rim. Cosmo Pharmaceuticals developed the MMX technology.