Baxalta has received marketing approval from the European Commission for its Obizur (Antihaemophilic Factor [ecombinant], Porcine Sequence) to treat adult patients with haemophilia A.
Acquired haemophilia A is a rare haemorrhagic disease where auto-antibodies against coagulation factor VIII, FVIII-neutralising antibodies (inhibitors), weaken the inherent coagulation system.
The approval was granted for Obizur to treat bleeding episodes in adult patients with acquired haemophilia caused by antibodies to Factor VIII (FVIII), a very rare and potentially life-threatening acute bleeding disorder.
Baxalta haematology president and executive vice-president Brian Goff said: "Gaining marketing authorisation 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."
Approval was based on the results of a global, prospective, controlled and multi-centre Phase II/III open-label clinical study, which assessed the efficacy and safety of Obizur in the treatment of serious bleeding episodes in adults with acquired haemophilia A.
According to the Baxalta, all patients treated with Obizur have demonstrated a positive response and clinical improvement, with FVIII activity levels at 20% or higher at 24 hours after the initial infusion.
Obizur is also approved in the US, Canada, and is under regulatory review in Switzerland, Australia and Colombia.
In July, Baxalta purchased Oncasper (pegaspargase) portfolio from Sigma-Tau Finanziaria for around $900m.
Oncasper is a biologic cancer therapy that is used as a component of multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukaemia (ALL).