Shire plc, the global specialty biopharmaceutical company, announced that the US 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 programmes, 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 multi-centre, 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 sub-score of less than or equal to 1. The endoscopy sub-score of less than or equal to 1 represented normal or mild disease with no friability.

Of the patients receiving Lialda 2.4 g/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 1.6 g/day (n=336) administered as 0.8 g 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 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.

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Lialda is available as a delayed-release tablet containing 1.2 g mesalamine. For the induction of remission in patients with active, mild to moderate ulcerative colitis, the recommended dosage is two or four 1.2 g tablets taken once daily with a meal. The recommended dosage for the maintenance of remission of ulcerative colitis is two 1.2 g tablets taken once daily with a meal.

Ulcerative colitis is a type of inflammatory disease. It only affects the colon, producing chronic inflammation and sometimes sores or ulcers along the inside lining of the colon. It is characterized by diarrhoea, which is generally bloody, and often painful cramping in the abdomen. Currently, there is no cure available with medical treatment, and the cause of the disease is unknown.

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. It focuses its business on Attention Deficit Hyperactivity Disorder (ADHD), Human Genetic Therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.