Octapharma updates on Balfaxar

Privately-held Swiss biotech Octapharma announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar (prothrombin complex concentrate, human-lans) have been published by the American peer-reviewed journal JAMA Network Open.

“We are pleased that JAMA Network Open has published the results of this important study,” said LEX-209 principal investigator Dr Ravi Sarode, who noted that “Balfaxar met the primary endpoint of hemostatic efficacy and was non-inferior to the comparator, CSL Behring’s Kcentra, in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.”

Approved last year by the US Food and Drug Administration, Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC) indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. Balfaxar contains vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. The drug is also marketed in Europe under the trade name Octaplex.