FDA approves Novo Nordisk’s Alhemo

Denmark’s Novo Nordisk (NOV: N) said late Friday that the US Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection.

The drug is authorized as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors, continuing its more than 35-year commitment to those living with rare bleeding disorders.1,2

Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist that is dosed in a prefilled, premixed pen for subcutaneous injection at various strengths. Currently, many treatments for hemophilia A or B with inhibitors are administered via intravenous infusions, and Alhemo is the first subcutaneous injection treatment of its kind for this population, the company said.