Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B.
Hemophilia B is the second most common type of haemophilia and results from insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding.
The submission is based on results of research with hemophilia B patients previously treated with other therapies and is further supported by data secured from a study of 23 hemophilia B patients less than 12 years old.
The Phase I/III trial in adult patients with severe or moderately severe hemophilia B showed that twice-weekly prophylactic treatment with Rixubis for six months achieved a median annualized bleed rate (ABR) of 2.0, with 43% of patients experiencing no bleeds.
In the trial, noo patients developed an inhibitory antibody to FIX and no cases of anaphylaxis were reported.
Baxter BioScience business vice president of global research and development Anders Ullman said, "Our focus at Baxter is to strengthen and expand the portfolio of treatments for patients with bleeding disorders, particularly when there are limited treatment options, such as for patients with hemophilia B."
Earlier in 2013, Rixubis was approved and introduced in the US and Puerto Rico for treatment in adult patients.
In the US, Rixubis is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults; perioperative management in adults and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia B.
