* Says Committee publishes positive opinion for drug
* Sees Europe approval in two to three months-CSO
(Adds details, CSO comments, share price)
COPENHAGEN, Sept 20 Danish insulin maker Novo
Nordisk has received a recommendation for marketing
approval from a European Medicines Agency (EMA) committee for
its haemophilia treatment turoctocog alfa.
The company said on Friday the Committee for Medicinal
Products for Human Use (CHMP) recommended approval of the drug,
also known as NovoEight, which belongs to a class of haemophilia
drugs called factor 8.
"We are very happy to now have treatment in this mainstream
haemophilia market, which we have never had before," said Chief
Science Officer Mads Krogsgaard Thomsen.
Thomsen said the total market for factor 8 haemophilia is
worth 35-40 billion Danish crowns ($6.36 billion to $7.26
billion) in terms of sales.
He said the company expects to receive final marketing
authorisation from the European Commission in two to three
The company said in the statement it expects 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 = 5.5067 Danish crowns)
(Reporting by Mette Fraende and Shida Chayesteh; Editing by