Octapharma USA: JAMA Network Open Publishes Study Results Demonstrating Efficacy & Safety of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

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.1

“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.3

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.

 WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

• Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events.

• Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months.

For complete boxed warning and full prescribing information, please visit Balfaxar.com/pi.

Balfaxar®, a lyophilized powder for reconstitution, is provided with sterile water for injection (diluent) and a transfer device, nextaro®. The transfer device includes an optimized vial housing that enables precentering of the vial during mounting, and optimized contamination protection with two integrated filters. Nextaro was preferred by healthcare professionals versus a widely used, competitive transfer device in an Octapharma user preference study.4

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has 40 years of experience in patient care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.

References

1 - Sarode R, Goldstein JN, Simonian G, et al. Vitamin K Antagonist Reversal for Urgent Surgery Using 4-Factor Prothrombin Complex Concentrates: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(8):e2424758. doi:10.1001/jamanetworkopen.2024.24758

2 - ClinCalc.com, Warfarin: Drug Usage Statistics, United States, 2013 - 2020, accessed June 25, 2024.

3 - Mayo Clinic, Warfarin side effects: Watch for interactions, accessed June 19, 2023.

4 - Data on file, Octapharma USA, Oct. 22, 2018.

Octapharma press releases are specifically for health specialist/medical media and are not for consumer press.