Merck's grass pollen allergy drug wins U.S. approval
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[April 15, 2014]
(Reuters) — 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.
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Merck's pollen treatment received regulatory approval in Canada in
February and has been available in Europe since 2006 under the name
Merck shares closed at $55.57 Monday on the New York Stock
(Reporting by Natalie Grover in Bangalore and Susan Kelly in
Chicago; editing by Savio D'Souza, Bernard Orr)
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