FDA approves LIALDA™ (mesalamine)
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Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDATM(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 MEZAVANTTM—(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.
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