FDA Approves Lialda for Maintenance of Remission in Ulcerative Colitis Patients

The U.S. Food and Drug Administration (FDA) has granted approval to Shire plc's Lialda® (mesalamine) Delayed Release Tablets for maintaining remission in patients with ulcerative colitis. This decision is based on a six-month study that showcased the drug's safety and efficacy in maintaining endoscopic remission among adult patients. Lialda had previously been approved by the FDA in 2007 for inducing remission in patients with active, mild to moderate ulcerative colitis.

The approval for the new indication was supported by a multicenter, randomized, double-blind, active comparator, non-inferiority study involving 826 adult patients in remission from ulcerative colitis. The study assessed the maintenance of remission using a modified Ulcerative Colitis Disease Activity Index (UC-DAI), focusing on endoscopic remission defined as a modified UC-DAI endoscopy subscore of less than or equal to 1. This score indicates normal or mild disease without friability.

In the study, 83.7% of patients receiving Lialda 2.4 g/day maintained remission at Month 6, a result comparable to the comparator group receiving mesalamine delayed-release 1.6 g/day. The safety of Lialda for maintaining remission was evaluated across three studies, with the most common adverse reactions being ulcerative colitis, headache, abnormal liver function test, and abdominal pain.

Lialda's initial approval in 2007 for inducing remission was based on two eight-week, placebo-controlled clinical studies. The drug is contraindicated for individuals allergic to salicylates or any of its ingredients. It is also associated with kidney function problems, and patients are advised to have their kidney function checked before and during therapy. Additionally, Lialda may cause symptoms similar to an ulcerative colitis flare-up, and patients experiencing such symptoms should consult their doctor immediately.

Lialda is available as a delayed-release tablet containing 1.2 g mesalamine, with recommended dosages for inducing and maintaining remission of ulcerative colitis. Ulcerative colitis is a chronic inflammatory disease affecting the colon, characterized by bloody diarrhea and abdominal cramping, with no known cure.