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news.Shire has received the US Food and Drug Administration (FDA) approval for Lialda (mesalamine) delayed release tablets for the maintenance of remission in patients with ulcerative colitis.
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The FDA approval was given on the basis of the results from a six-month study, which demonstrated that the drug is safe and effective in maintaining endoscopic remission in adult patients.
Lialda’s new indication is based on results from a multicenter, randomized, double-blind, active comparator, non-inferiority study conducted in 826 adult patients in remission from ulcerative colitis.
Shire Gastrointestinal Business SVP Roger Adsett said this new indication is an important milestone for Lialda as it provides a once-daily option for both inducing remission in patients with active, mild to moderate ulcerative colitis and maintaining remission of ulcerative colitis.