COPENHAGEN (Reuters) - Danish insulin maker Novo Nordisk has received a recommendation for marketing approval from a European Medicines Agency (EMA) committee for its hemophilia 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 hemophilia drugs called factor 8.
“We are very happy to now have treatment in this mainstream hemophilia market, which we have never had before,” said Chief Science Officer Mads Krogsgaard Thomsen.
Thomsen said the total market for factor 8 hemophilia 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 authorization from the European Commission in two to three months.
The company said in the statement it expects to launch the drug in Europe early next year.
NovoEight has also been filed for marketing authorization in the United States, Japan, Australia and Switzerland.
($1 = 5.5067 Danish crowns)
Reporting by Mette Fraende and Shida Chayesteh; Editing by Elaine Hardcastle