Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B.
The company said that the DNA derived haemophilia B therapy is clinically proven to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
Developed using a process called Fc fusion, Alprolix is the first haemophilia therapy to show prolonged circulation in the body, which has been shown in adults and adolescents with haemophilia to extend the time between prophylactic infusions.
The National Hemophilia Foundation (NHF) recommends routine prophylaxis as optimal for the treatment of people with severe haemophilia, the company said.
The clinical trials have showed that people with severe haemophilia who follow this type of regimen experience fewer bleeding episodes and their related risks.
The approval is based on results from the global, Phase III B-LONG trial, as well as interim pharmacokinetic and safety data from the Phase III Kids B-LONG trial.
The results from the B-LONG trial showed that adults and adolescents with severe hemophilia B achieved prevention or reduction of bleeding episodes with prophylactic infusions at least a week apart.
The drug is expected to be commercially available to people with haemophilia B in the US in early May 2014.