Baxalta Gets EU Nod for Hemophilia Treatment
US biopharmaceutical company Baxalta has received European marketing approval for its hemophilia treatment Obizur. The drug is said to be the first recombinant porcine sequence FVIII treatment available in Europe to treat acquired hemophilia A in adults.
Acquired hemophilia A is a rare hemorrhagic disease caused by antibodies to coagulation factor VIII, or FVIII. Baxalta said Obizur can help doctors to monitor a patient’s response by measuring FVIII activity levels.
The approval is supported by positive results from a global Phase 2/3 trial where all patients given Obizur had increased FVIII activity levels of 20% or more 24 hours after the initial dose.
Obizur is also approved in Canada and the US and is being reviewed in Switzerland, Australia and Colombia.
Meanwhile, Baxalta’s manufacturing facility in Singapore has received approval from the US Food and Drug Administration (FDA) to produce Advate (antihemophilic factor [recombinant]). The company said the approval is a key milestone in its manufacturing strategy, enabling continued growth of its global FVIII portfolio.
The plant was approved to produce Advate by the European Medicines Agency in January 2014 and since when it has supplied the EU, Iceland and Norway.