Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
AssigneeAlexion Pharmaceuticals, Inc.
InventorsLori PAYTON, Scott T. ROTTINGHAUS, Rajendra PRADHAN, Andrew DAMOKOSH, Xiang GAO
Life of this patent
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Abstract
Provided are methods for clinical treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS) using an anti-C5 antibody, or antigen binding fragment thereof.
Claims21
1-59. (canceled)
A method of treating a human patient with a complement-associated condition, the method comprising administering to the patient during an administration cycle an effective amount of an anti-C5 antibody comprising a heavy chain polypeptide of SEQ ID NO:
- 14 and a light chain polypeptide sequence of SEQ ID NO:
- 11, wherein the anti-C5 antibody is administered in administration cycle comprising:
- (a) once on Day 1 of the administration cycle at a dose of:
- 2400 mg to a patient weighing >40 to <60 kg, 2700 mg to a patient weighing >60 to <100 kg, or 3000 mg to a patient weighing >100 kg;
- and
- (b) on Day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing >40 to <60 kg, 3300 mg to a patient weighing >60 to <100 kg, or 3600 mg to a patient weighing >100 kg.
A kit for treating PNH or aHUS in a human patient, the kit comprising:
- (a) a dose of an anti-C5 antibody, or antigen binding fragment thereof, comprising CDR1, CDR2 and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO:
- 12, and CDR1, CDR2 and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:8;
- and (b) instructions for using the anti-C5 antibody in the therapeutic method of claim 1.
A method of treating a human patient having a complement-associated disorder who is being treated a first anti-C5 antibody, the method comprising discontinuing treatment with the first anti-C5 antibody, and switching the patient to treatment with a different complement inhibitor, wherein the first anti-C5 antibody comprises eculizumab and the different complement inhibitor comprises ravulizumab.
Dependencies are inferred from the claim text.