Obizur is indicated to treat bleeding episodes in adult patients with acquired haemophilia caused by antibodies to Factor VIII (FVIII), a life-threatening acute bleeding disorder.
It will allow physicians to monitor treatment response by measuring FVIII activity levels apart from clinical assessments.
Results from a Phase II/III open-label clinical trial of Obizur demonstrated a positive response and clinical improvement, with FVIII activity levels at 20% or more at 24 hours following the first infusion.
Baxalta said successful control of the initial bleeding episode was observed in 86% of all patients and in 94% of those treated with Obizur as the first-line treatment.
The development of antibodies to porcine factor VIII was the only adverse reaction reported in over 5% of patients.
Baxalta executive vice president and president of haematology Brian Goff said: "Gaining Marketing Authorization for this first recombinant porcine option for acquired haemophilia in Europe reflects Baxalta’s commitment to improving patient lives.
"We continue to build a broad, global portfolio of treatments that aim to reduce the burden of bleeding disorders for patients as we pursue a world without bleeds."
Apart from Europe, Obizur is also approved in the US and Canada. It is under regulatory review in Switzerland, Australia and Colombia.