Use of milvexian in the treatment and prevention of thrombotic conditions in patients with atrial fibrilation
AssigneesBristol-Myers Squibb Company, Jansssen Pharmaceutica N.V.
InventorsJohn STRONY, Gary PETERS, Madhu CHINTALA, Christopher NESSEL, Danshi LI, Joseph LUETTGEN, Puneet MOHAN, Jay HORROW
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Abstract
The disclosure provides methods of using milvexian for treating or preventing thrombotic events in human patients with atrial fibrillation or flutter.
Claims19
A method for preventing one or more of stroke and non-central nervous system (CNS) systemic embolism events in a human patient with a history of atrial fibrillation, wherein the method comprises administering to the human patient a pharmaceutical composition comprising 100 mg of milvexian (or a pharmaceutically acceptable salt or solvate thereof, on a milvexian basis);
- wherein the pharmaceutical composition is administered twice daily.
A method for preventing one or more of adverse cardiovascular events in a patient with a history of atrial fibrillation, wherein each event is selected from the group consisting of cardiovascular death, myocardial infarction, stroke, and non-central nervous system (CNS) systemic embolism, wherein the method comprises administering to the human patient a pharmaceutical composition comprising 100 mg of milvexian (or a pharmaceutically acceptable salt or solvate thereof, on a milvexian basis);
- wherein the composition is administered twice daily.
A method of preventing one or more of stroke and non-central nervous system (CNS) systemic embolism events in a patient with a history of atrial fibrillation, wherein the method comprises administering to the patient an immediate release film coated tablet comprising 100 mg of milvexian or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients,
- wherein the immediate release film-coated tablet is administered twice a day with or without a meal,
- wherein the patient is at least 18 years old;
- wherein the patient further has one or more of category (A) risk factors selected from (i) age greater than or equal to 75 years or (ii) history of ischemic stroke or silent brain infarct;
- or two or more of concomitant or comorbid category (B) cardiovascular risk factors selected from the group consisting of:
- (i) age between 65 and 74 years;
- (ii) hypertension;
- (iii) diabetes mellitus;
- (iv) history of coronary artery disease (CAD) (including post myocardial infarction or an acute coronary syndrome event with or without percutaneous coronary intervention (PCI)) or peripheral artery disease (PAD);
- and
- (v) history of heart failure.
A method of preventing one or more adverse cardiovascular events in a patient with a history of atrial fibrillation, wherein each event is selected from the group consisting of cardiovascular death, myocardial infarction, stroke, and non-central nervous system (CNS) systemic embolism, said method comprising administering to the patient an immediate release film-coated tablet comprising 100 mg of milvexian, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients,
- wherein the immediate release film-coated tablet is administered twice a day with or without a meal,
- wherein the patient is at least 18 years old;
- wherein the patient further has one or more of category (A) risk factors selected from (i) age greater than or equal to 75 years or (ii) history of ischemic stroke or silent brain infarct;
- or two or more of concomitant or comorbid category (B) cardiovascular risk factors selected from the group consisting of:
- (i) age between 65 and 74 years;
- (ii) hypertension;
- (iii) diabetes mellitus;
- (iv) history of coronary artery disease (CAD) (including post myocardial infarction or an acute coronary syndrome event with or without percutaneous coronary intervention (PCI)) or peripheral artery disease (PAD);
- and
- (v) history of heart failure.
Dependencies are inferred from the claim text.