Methods for treating intracranial hemorrhage and assessing efficacy
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12685763-B2
Publication Date
2026-07-21
Expiration Date
Abstract
Compositions and methods useful for assessing the hemostatic efficacy in a patient having suffered from intracranial hemorrhage while undergoing an anticoagulation treatment with a factor Xa (fXa) inhibitor are described. The method can include administering to the patient a fXa derivative that has reduced catalytic activity as compared to the wild-type fXa protein, is capable of binding to the factor Xa inhibitor and cannot assemble into a prothrombinase complex; obtaining a blood sample from the patient following the administration; and measuring an anti-fXa activity in the sample, wherein the anti-fXa activity reflects the hemostatic efficacy in the patient. Once the assessment is made, suitable medical interventions can be implemented.
Core Innovation
The invention relates to a method for treating intracranial hemorrhage in a patient undergoing anticoagulation treatment with a factor Xa (fXa) inhibitor. The method comprises administering andexanet alfa, which binds the fXa inhibitor but cannot assemble into the prothrombinase complex, and thereby exhibits reduced catalytic activity.
After administration, the method obtains a blood sample and measures anti-fXa activity in the sample. The anti-fXa activity is used to decide whether to administer a second dose of andexanet alfa, and the method does not comprise measuring hemostatic efficacy in the patient.
A generally unexpected correlation is described between post-administration anti-fXa activity and hemostatic efficacy specifically in intracranial hemorrhage patients. The disclosed approach uses an anti-fXa activity measurement approach such as a chromogenic assay and a post-administration blood sampling time window, and distinguishes inhibitor-specific predetermined anti-fXa activity threshold ranges depending on the particular fXa inhibitor used.
Claims Coverage
The independent claim is clm-00001. It covers an intracranial hemorrhage treatment workflow that administers andexanet alfa, measures anti-fXa activity after administration, and uses a predetermined anti-fXa activity threshold to determine whether to administer a second dose, without measuring hemostatic efficacy.
Treating intracranial hemorrhage with andexanet alfa during fXa inhibitor anticoagulation
Administering andexanet alfa to a patient undergoing an anticoagulation treatment with a factor Xa (fXa) inhibitor who has suffered intracranial hemorrhage.
Post-administration anti-fXa activity measurement for second-dose decision
Obtaining a blood sample following the administration and measuring an anti-fXa activity in the sample.
Second dose based on predetermined anti-fXa activity threshold without hemostatic efficacy measurement
Administering a second dose of the andexanet alfa if the anti-fXa activity is above a predetermined anti-fXa activity threshold, wherein the method does not comprise measuring hemostatic efficacy in the patient.
Inhibitor-specific anti-fXa activity threshold ranges for second dose decision
Using predetermined anti-fXa activity threshold ranges that depend on the fXa inhibitor used.
Timing and assay specification for anti-fXa measurement
Collecting the blood sample 10 minutes to 4 hours after administration and measuring the anti-fXa activity using a chromogenic assay.
Bolus and optional bolus-plus-infusion administration of andexanet alfa
Administering andexanet alfa by bolus injection, optionally followed by an infusion after the bolus injection.
Across the independent claim and its refinements, the claims focus on deciding whether to administer a second andexanet alfa dose using post-administration anti-fXa activity compared to a predetermined threshold, with inhibitor-specific threshold ranges and with anti-fXa measurement, while expressly not measuring hemostatic efficacy.
Stated Advantages
Enables administration of a second dose of andexanet alfa based on a biomarker (anti-fXa activity) using a predetermined anti-fXa activity threshold.
Does not require measuring hemostatic efficacy in the patient to guide the second-dose decision.
Documented Applications
Treating intracranial hemorrhage using an andexanet alfa dosing approach guided by measured anti-fXa activity above a predetermined threshold.
Supporting surgical decision-making in intracranial hemorrhage patients based on the anti-fXa activity correlation.
Preventing thrombotic event risk and supporting monitoring/discharge timing in intracranial hemorrhage patients based on the disclosed anti-fXa activity approach.
Interested in licensing this patent?