Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (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.
"At Shire, we strive to create meaningful therapies for patients with our clinical programs, and this approval based on our large clinical trial underscores our commitment and dedication to the ulcerative colitis community," said Roger Adsett, Senior Vice President of Shire's Gastrointestinal business. "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."
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.
Safety of Lialda in the maintenance of remission of ulcerative colitis was evaluated in three studies, one being the 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.
In 2007, Lialda gained FDA approval for the induction of remission in patients with active, mild to moderate ulcerative colitis as a result of two eight-week, placebo-controlled clinical studies demonstrating safety and effectiveness.