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【medical-news】FDA批准了首个、每天一次的口服5
Public release date: 16-Jan-2007
FDA approves LIALDA?(mesalamine), the first oral once-daily mesalamine
Basingstoke, UK and Philadelphia, US ?January 16, 2007 -- 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. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 抱歉，这两天较忙，请其他战友认领此篇。 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 FDA approves LIALDA?(mesalamine)
FDA批准LIALDA（美沙拉嗪）
The first oral once-daily mesalamine for patients with active, mild to moderate ulcerative colitis
首个用于治疗活动期轻度至中度溃疡性结肠炎的每日一次的口服美沙拉嗪
Basingstoke, UK and Philadelphia, US ?January 16, 2007 -- 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.
贝辛斯托克（英国）和费城（美国）2007年1月16日——Shire制药公司(伦敦证券交易所代码:SHP;纳斯达克交易代码:SHPGY;多伦多证券交易所代码:SHQ)今日宣布，美国FDA已经批准具有MMX技术的LIALDA（美沙拉嗪）用于活动期轻度至中度溃疡性结肠炎的诱导缓解治疗。LIALDA是FDA首个、也是唯一批准的一日一次的口服美沙拉嗪制剂。美沙拉嗪属于氨基水杨酸类药物，含有5-氨基水杨酸（5-ASA），后者是一种常用的、也是治疗轻度至中度溃疡性结肠炎的一线药物。Shire制药公司的LIALDA将于2007年第一季度在美国上市。
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作者:admin@医学,生命科学 2011-03-25 05:16
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