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EMA panel backs Novo Nordisk’s hemophilia B drug

EMA panel backs Novo Nordisk’s hemophilia B drug

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.

Source: Reuters
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