A panel of the European Medicines Agency said it recommended granting marketing approval to Danish drug maker Novo Nordisk’s hemophilia B drug.
The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, Refixia, intended for the treatment and prevention of bleeding in patients 12 years and above with hemophilia B.
Hemophilia B is caused by the deficiency of the factor IX gene that is instrumental in blood clotting.
The panel’s opinion will now be reviewed by the EMA.
The positive recommendation comes at a time when Novo Nordisk struggles with declining sales from its aging diabetes franchise.
Last month, the Danish group warned that sales and profits might actually slip in 2017, a remarkable change in fortune for a company that was previously renowned for its sector-beating growth.
Outside diabetes, Novo Nordisk already has a significant blood products business focused on hemophilia.
