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FDA批准Merck草花粉过敏疫苗Grastek

发布时间:2014年04月16日 16:17:54

默沙东4月14日表示,美国FDA批准其草花粉过敏疫苗Grastek用于5至65岁患者。这款片剂药物由默沙东与丹麦ALK Abello公司共同开发,默沙东表示有望4月底在美国将这款药物推向市场。

 

FDA顾问委员会去年10月份一致投票推荐批准这款药物。这款免疫治疗药物还于2月份在加拿大获得批准。
 

Merck's grass pollen allergy drug wins U.S. approval

 

Merck & Co said the U.S. Food and Drug Administration on Monday approved its grass pollen allergy drug Grastek, becoming the second such immunotherapy treatment to be given the go-ahead in recent weeks.

 

The company, which developed the tablet with Denmark's ALK Abello, said it expects to launch the drug, approved for patients age 5 to 65, in the United States by late April.

 

Immunotherapies work by boosting the body's immune system and making it less sensitive to allergens.

 

Grastek contains extracts of the timothy grass allergen. The tablet is placed under the tongue and dissolves.

 

An advisory committee to the FDA unanimously recommended approval of the drug in December. Panelists also called for post-approval studies to test the product's safety in children, citing side effects such as lip swelling, throat irritation and oral blistering.

 

Earlier this month, the FDA approved Stallergenes' immunotherapy treatment for five types of grass pollen.

 

The French company has said it sees a potential U.S. market of nearly 3 million patients that will eventually be worth $1 billion in annual sales for these types of drugs.

 

Merck's pollen treatment received regulatory approval in Canada in February and has been available in Europe since 2006 under the name Grazax.

 

Merck shares closed at $55.57 Monday on the New York Stock Exchange.

 

 

 

 

 

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