FDA委员会反对批准默沙东顺尔宁用作非处方药

关键词:顺尔宁,默沙东,Singulair,非处方药

2014年5月5日讯 /生物谷BIOON/ --FDA顾问委员会5月3日以11:4的投票结果,反对批准默沙东(Merck & Co)顺尔宁(Singulair)以一种非处方(OTC)抗过敏药销售。

该委员会反对无处方使用该药。目前,默沙东销售顺尔宁作为一种处方药用于哮喘和过敏的治疗。

大多数过敏药是通过阻断组胺的释放发挥作用,而顺尔宁则是阻断一种能引发炎症的蛋白--白三烯。顺尔宁是一种白三烯拮抗剂(leukotriene antagonist),该药曾是默沙东最畅销的药物,已被广泛应用于过敏性鼻炎及哮喘的治疗,最风光时,年销售额超过50亿美元。自专利于2012年中期到期之后,该药的销售额暴跌。

默沙东正寻求批准顺尔宁作为一种非处方抗过敏药,来重振该药的雄风。

不过,FDA委员会称,顺尔宁作为非处方药的安全性尚未证实,特别是患者可能会将该药标签外用药,用于一些更严重的疾病,如哮喘。(生物谷Bioon.com)

英文原文:FDA panel votes against Merck proposal to sell Singulair over-the-counter for allergies

WASHINGTON - Federal health advisers have voted against a Merck proposal to sell its prescription respiratory pill Singulair as an over-the-counter allergy medication.

The Food and Drug Administration's panel of experts voted 11-4 Friday against making the drug available without a prescription. Merck sells Singulair via prescription for asthma and allergies.

Singulair was once Merck's bestselling drug, but sales have plummeted since the drug's patent expired in mid-2012, exposing the brand to low cost generics.
Merck & Co. Inc. hopes to revive sales of the former blockbuster as an over-the-counter allergy medication.

But FDA's advisers said the safety of Singulair as an over-the-counter treatment has not been established, particularly since patients could use it off-label for more serious conditions like asthma.

The FDA is not required to follow the expert panel's vote.

(责任编辑:lishuheng)

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