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FDA Approves Lialda(TM) (Mesalamine), the First Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis

BASINGSTOKE, UK, and PHILADELPHIA, PA, US -- January 17, 2007 -- Shire plc announced today that the U.S. Food and Drug Administration (FDA) has approved Lialda™ (mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Lialda is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch Lialda in the U.S. in the first quarter of 2007.

Once-daily Lialda with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn's and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.

"As the first oral once-a-day treatment option for ulcerative colitis, the approval of Lialda in the United States is great news for patients and physicians when managing this serious condition," said Matthew Emmens, Shire Chief Executive Officer. "Once-daily Lialda is one of several medicines Shire expects to launch in the U.S. and Europe in 2007."

The FDA approval was based on the results of two Phase III clinical studies that found Lialda (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment. Lialda is generally well tolerated and has a similar safety profile to other currently available mesalamines.

"In clinical trials, Lialda proved to be an effective medication, providing superior rates of remission compared to placebo for people with ulcerative colitis," said lead study investigator, Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania. "This is the first new mesalamine treatment to enter the market since 2000, filling a major void for physicians and people with ulcerative colitis and simplifying treatment of this disease."

"The introduction of new treatments with more convenient dosing regimens may be an important step in helping patients with ulcerative colitis remain compliant with their medication," said Jonathan Braun, M.D., Ph.D., chair of CCFA's National Scientific Advisory Committee.

Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and commercialize Lialda in the U.S., Canada, Europe -- known as Mezavant™ -- (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX technology and owns the trademark, MMX.

Important Safety Information
Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda beyond eight weeks has not been established.

Lialda is generally well tolerated. The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment related adverse events with Lialda 2.4 g/day and 4.8 g/day were headache (5.6 percent and 3.4 percent, respectively) and flatulence (4 percent and 2.8 percent, respectively). Lialda is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of Lialda. Caution should be used in patients with impaired hepatic or renal function.

MMX Technology
Lialda is the only ulcerative colitis treatment that utilizes novel MMX technology. Lialda with MMX technology combines a pH dependant gastro-resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis) with a tablet core containing mesalamine with hydrophilic and lipophilic excipients.

Clinical Studies
The approval of Lialda was based on the results of two Phase III clinical studies. The first study assessed the efficacy and safety of Lialda 2.4 g/day given in divided doses twice daily and 4.8 g/day given once daily against placebo in 262 patients. At eight weeks, both doses demonstrated superiority over placebo in the induction of remission (34.1 percent with 2.4 g/day, 29.2 percent with 4.8 g/day, and 12.9 percent with placebo). The second study assessed the efficacy and safety of Lialda 2.4g/day and 4.8g/day (both given once daily) against placebo in 255 patients. At eight weeks, both once daily doses demonstrated superiority over placebo in the induction of remission (40.5 percent with 2.4 g/day, 41.2 percent with 4.8 g/day, and 22.1 percent with placebo).

About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease that produces inflammation and sores or ulcers along the inside of the large intestine, also called the bowel or colon. The sores interfere with the normal digestive process, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. This serious, chronic autoimmune disease affects approximately 500,000 Americans. For an informative white paper on ulcerative colitis, visit www.managinguc.com.


SOURCE: Shire plc

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