FDA approves LialdaR
Shire, a global biopharmaceutical company, reported the FDA approved LialdaR (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.
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.
Maintenance of remission was assessed using a modified Ulcerative Colitis Disease Activity Index (UC-DAI) and was based on maintaining endoscopic remission defined as a modified UC-DAI endoscopy subscore of less than or equal to 1. The endoscopy subscore of less than or equal to 1 represented normal or mild disease with no friability.
Of the patients receiving Lialda 2.4g/day (n=343) administered once daily, 83.7% maintained remission at Month 6, which was similar to that seen using the comparator, mesalamine delayed-release 1.6g/day (n=336) administered as 0.8g given twice daily (81.5%, 95% confidence interval for difference: -3.9%, 8.1%).
Safety of Lialda in the maintenance of remission of ulcerative colitis was evaluated in three studies, one being a six-month, double-blind, non-inferiority, comparator study and two being 12- to 14-month open-label studies. The most common adverse reactions with Lialda in the maintenance arms of these three trials were ulcerative colitis, headache, abnormal liver function test and abdominal pain. The most common severe adverse reactions were gastrointestinal disorders, most of which are consistent with symptoms associated with ulcerative colitis.