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Last Updated: January 29, 2022

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Claims for Patent: 9,556,263

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Summary for Patent: 9,556,263
Title:Methods for treating atypical hemolytic uremic syndrome with high concentration formulations of anti-C5 antibodies
Abstract: The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.
Inventor(s): Zhou; Xiao-Hong (Madison, CT), Wang; Yi (Woodbridge, CT)
Assignee: Alexion Pharmaceuticals, Inc. (New Haven, CT)
Application Number:15/176,774
Patent Claims:1. A method for treating a patient having atypical hemolytic uremic syndrome (aHUS) comprising administering to the patient a stable aqueous solution comprising: (a) eculizumab at a concentration of about 100 mg/mL to about 200 mg/mL, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol.

2. A method for treating a patient having atypical hemolytic uremic syndrome (aHUS) comprising administering to the patient a stable aqueous solution consisting of: (a) eculizumab at a concentration of about 100 mg/mL to about 200 mg/mL, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol.

3. A method for treating a patient having paroxysmal nocturnal hemoglobinuria (PNH) comprising administering to the patient a stable aqueous solution comprising: (a) eculizumab at a concentration of about 100 mg/mL to about 200 mg/mL, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol.

4. A method for treating a patient having paroxysmal nocturnal hemoglobinuria (PNH) comprising administering to the patient a stable aqueous solution consisting of: (a) eculizumab at a concentration of about 100 mg/mL to about 200 mg/mL, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol.

5. The method of any one of claims 1-4, wherein the pH of the solution is between 6.5 and 7.5.

6. The method of claim 5, wherein the pH of the solution is 7.0.

7. The method of any one of claims 1-4, wherein the anti-C5 antibody is at a concentration of 100 mg/mL.

8. The method of any one of claims 1-4, wherein the anti-C5 antibody remains at least 97% monomeric during storage at 2.degree. C. to 8.degree. C. for at least six months as determined by SEC-HPLC.

9. The method of any one of claims 1-4, wherein the anti-C5 antibody remains at least 97% monomeric during storage at 2.degree. C. to 8.degree. C. for at least one year as determined by SEC-HPLC.

10. The method of any one of claims 1-4, wherein less than 2% of the anti-C5 antibody in the solution is aggregated as determined by SEC-HPLC.

11. The method of any one of claims 1-4, wherein less than 1% of the anti-C5 antibody in the solution is fragmented as determined by SEC-HPLC.

12. The method of any one of claims 1-4, wherein during storage at 2.degree. C. to 8.degree. C. for at least six months the anti-C5 antibody retains at least 90% of its C5-binding activity, as compared to a reference anti-C5 antibody corresponding to the anti-C5 antibody prior to storage.

13. The method of any one of claims 1-4, wherein during storage at 2.degree. C. to 8.degree. C. for at least six months the anti-C5 antibody retains at least 95% of its ability to inhibit hemolysis, as compared to a reference anti-C5 antibody corresponding to the anti-C5 antibody prior to storage.

14. The method of any one of claims 1-4, wherein the anti-C5 antibody is administered by intravenous infusion.

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