Octapharma USA announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) have been published by the JAMA Network Open, an American Medical Association peer-reviewed journal.
"We are pleased that JAMA Network Open has published the results of this important study," said LEX-209 Principal Investigator Ravi Sarode, M.D. "Balfaxar® met the primary endpoint of hemostatic efficacy and was non-inferior to the comparator, Kcentra®, in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk."
Approved last year by the U.S. 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, e.g., 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.
"Octapharma launched Balfaxar® in the U.S. earlier this year and the response from the medical community has been outstanding," said Octapharma USA President Flemming Nielsen. "The journal article provides further reinforcement of the great value this life-saving therapy has for patients. Octapharma is committed to ensuring a consistent Balfaxar® supply for hospitals and medical providers now and in the future."
Warfarin Use & Side Effects:
More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming following a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for certain types of irregular heartbeat (atrial fibrillation).2 The main side effect of warfarin is an increased risk of bleeding particularly for patients undergoing urgent surgery or invasive procedures.
About LEX-209:
The FDA approval of Balfaxar® was supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study evaluated 208 adult patients who received Balfaxar® (N=105) or control 4F-PCC (N=103).
Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk. Balfaxar® demonstrated effective hemostasis in 94.3% of patients versus 94.2% of patients for Kcentra®. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.1
About Balfaxar®:
Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.
For more information, please visit octapharmausa.com.
