FDA Approves Balfaxar (prothrombin advanced focus, human-lans) for Warfarin Reversal in Pressing Surgical procedure & Invasive Procedures

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FDA Approves Balfaxar (prothrombin advanced focus, human-lans) for Warfarin Reversal in Pressing Surgical procedure & Invasive Procedures

PARAMUS, N.J., July 26, 2023 /PRNewswire/ — Octapharma USA as we speak introduced that Balfaxar® (prothrombin advanced focus, human-lans; marketed in Europe and Canada as octaplex®) has obtained U.S. Meals and Drug Administration (FDA) approval for the pressing reversal of acquired coagulation issue deficiency induced by vitamin Okay antagonist (VKA, e.g., warfarin) remedy in grownup sufferers with want for pressing surgical procedure or invasive procedures.

Balfaxar® helps restore blood coagulation by replenishing the degrees of clotting components which might be poor attributable to warfarin remedy. Balfaxar® is a non-activated 4 issue prothrombin advanced focus (4F-PCC) containing vitamin Okay-dependent components: Issue II (prothrombin), Issue VII, Issue IX and Issue X, in addition to antithrombotic Proteins C and S.

“Balfaxar® met the first endpoint of hemostatic efficacy and was non-inferior to the comparator, Kcentra®, in sufferers on a vitamin Okay antagonist present process pressing surgical procedure with vital bleeding threat,” stated LEX-209 Principal Investigator Ravi Sarode, M.D. “The first goal was met on the prespecified interim evaluation and the research was stopped attributable to statistically vital efficacy outcomes indicating that Balfaxar® was non-inferior to Kcentra®. Balfaxar® demonstrated efficient hemostasis in 94.6% of sufferers versus 93.5% of sufferers for Kcentra®. Worldwide Normalized Ratio (INR) reductions and vitamin Okay dependent coagulation issue will increase supported the first endpoint and PCC dosing and length of infusion had been additionally comparable. The protection profile was comparable between remedy arms and in step with earlier research.”1

Greater than 2.4 million U.S. sufferers are prescribed warfarin to forestall blood clots from forming following a coronary heart assault, coronary heart valve surgical procedure, stroke, deep vein thrombosis/pulmonary embolism, or for sure kinds of irregular heartbeat (atrial fibrillation).2 The primary aspect impact of warfarin is an elevated threat of bleeding notably for sufferers present process pressing surgical procedure or invasive procedures.3

“The FDA approval of Balfaxar® establishes a brand new remedy for medical suppliers when their sufferers want a 4F-PCC product,” stated Octapharma USA President Flemming Nielsen. “Octapharma is dedicated to offering sufferers with life-saving and life-enhancing therapies for vital care medication. We’re assured Balfaxar® will likely be a welcomed remedy for physicians who must shortly restore sufferers’ coagulation.”

Balfaxar®, a lyophilized powder for reconstitution, will likely be supplied with sterile water for injection and the brand new switch machine, nextaro®. The switch machine contains an optimized vial housing that permits precentering of the vial throughout mounting, and optimized contamination safety with two built-in filters. Nextaro® was most well-liked by healthcare professionals versus a broadly used, aggressive switch machine in an Octapharma person choice research.4

To review Balfaxar® additional in different medical eventualities, Octapharma is recruiting for 2 extra Section III research:

For extra info on LEX-210 and LEX-211, please go to ClinicalTrials.gov.

Kcentra® is a registered trademark of CSL Behring GmbH.

Nextaro® is a registered trademark of sfm medical units GmbH.

About Balfaxar®

Balfaxar® (prothrombin advanced focus, human-lans) is a blood coagulation issue alternative product indicated for the pressing reversal of acquired coagulation issue deficiency induced by Vitamin Okay antagonist (VKA, e.g., warfarin) remedy in grownup sufferers with want for an pressing surgical procedure/invasive process.

WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS

Sufferers being handled with Vitamin Okay antagonists (VKA) remedy have underlying illness states that predispose them to thromboembolic occasions. Potential advantages of reversing VKA must be weighed in opposition to the potential dangers of thromboembolic occasions, particularly in sufferers with the historical past of a thromboembolic occasion. Resumption of anticoagulation must be fastidiously thought of as quickly as the chance of thromboembolic occasions outweighs the chance of acute bleeding.

  • Each deadly and non-fatal arterial and venous thromboembolic problems have been reported with Balfaxar® in medical trials and publish advertising surveillance. Monitor sufferers receiving Balfaxar® for indicators and signs of thromboembolic occasions.
  • Balfaxar® will not be appropriate in sufferers with thromboembolic occasions within the prior 3 months.

For full boxed warning and full prescribing info, please go to Balfaxar.com/pi.

Concerning the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is without doubt one of the largest human protein producers on the planet, growing and producing human proteins from human plasma and human cell traces.

Octapharma employs greater than 11,000 individuals worldwide to assist the remedy of sufferers in 118 nations with merchandise throughout three therapeutic areas: Hematology, Immunotherapy and Important Care.

Octapharma has seven R&D websites and 5 state-of-the-art manufacturing amenities in Austria, France, Germany and Sweden, and operates greater than 190 plasma donation facilities throughout Europe and the US. The corporate’s American subsidiary, Octapharma USA, is positioned in Paramus, N.J. For extra info, please go to octapharmausa.com.

REFERENCES
1 – Ravi Sarode, Joshua N. Goldstein, Gregory Simonian, Truman J. Milling Jr; A Section 3, Potential, Randomized, Double-Blind, Multicenter, Non-Inferiority Examine Evaluating Two 4-Issue Prothrombin Advanced Concentrates for Reversal of Vitamin Okay Antagonist-Induced Anticoagulation in Sufferers Needing Pressing Surgical procedure with Vital Bleeding Danger. Blood 2022; 140 (Complement 1): 352–353. doi: https://doi.org/10.1182/blood-2022-168890

2 – ClinCalc.com, Warfarin: Drug Utilization Statistics, United States, 2013 – 2020, accessed June 19, 2023.

3 – Mayo Clinic, Warfarin negative effects: Look ahead to interactions, accessed June 19, 2023.

4 – Information on file, Octapharma USA, Oct. 22, 2018.

SOURCE Octapharma USA

Balfaxar (prothrombin advanced focus, human-lans) FDA Approval Historical past

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