Novo Nordisk gets final EU approval for haemophilia drug

COPENHAGEN Mon Dec 9, 2013 3:20pm EST

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COPENHAGEN Dec 9 (Reuters) - Novo Nordisk received European Union marketing authorisation for its haemophilia drug NovoEight on Nov. 13 2013, the Danish pharmaceutical company said on Monday.

The world's biggest insulin producer confirmed that the European Medicines Agency (EMA) approved its marketing application after it had received a recommendation from the Committee for Medicinal Products for Human Use on Sept. 20.

The approval appeared from EMA's assessment report for NovoEight, which was published on Monday.

The total market for the class of haemophilia drugs NovoEight belongs to, factor 8, is worth between 35 billion and 40 billion Danish crowns ($6.44-7.36 billion), Novo said in September. The company said it expected to launch the drug in Europe early next year.

NovoEight has also been filed for marketing authorisation in the United States, Japan, Australia and Switzerland.

($1 = 5.4375 Danish crowns) (Reporting by Stine Jacobsen, additional reporting by Teis Jensen; editing by David Evans)

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