Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) .
The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is 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.
"The availability of Balfaxar® brings a welcome new treatment option for medical providers around the country," said Josh Goldstein, MD, PhD, Professor of Emergency Medicine at Harvard Medical School and Massachusetts General Hospital. "More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming in patients who are at high risk.1 Unfortunately,
the main side effect of warfarin is an increased risk of bleeding, which can complicate urgent surgery or invasive procedures.2 Clinical research has demonstrated that Balfaxar® is extremely effective in restoring blood coagulation by replenishing the levels of clotting factors that are deficient in those patients on warfarin."
Balfaxar® is a non-activated 4F-PCC containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S.
"We are excited to announce the availability of Balfaxar® and are committed to providing the medical community with a valuable life-saving therapy," said Octapharma USA President Flemming Nielsen. "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future. We look forward to working with our critical care medicine partners to ensure patients receive the absolute best treatments available."
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 randomized 208 patients to 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. The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results.
Balfaxar® demonstrated effective hemostasis in 94.6% of patients versus 93.5% 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.
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 www.octapharmausa.com.