IP Library › Granted Patent US 12,391,749
Granted Patent B2
US 12,391,749 · App. 18/173,116 · Granted Aug 19, 2025

Acute treatment and rapid treatment of headache using anti-CGRP antibodies

Inventors: Roger K. Cady (Bothell, WA); Jeffrey T. L. Smith (Dublin, IE); Joseph Hirman (Bothell, WA); Barbara Schaeffler (Bothell, WA); Lahar Mehta (Valby, DK)
Assignee: H. Lundbeck A/S
C07K16/18A61K9/0019A61K31/4172A61K39/3955A61K45/06A61K47/26A61P25/06A61K38/00A61K2039/505A61K2039/545C07K2317/24
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Quick Facts
Patent No.
US 12,391,749
App. No.
18/173,116
Granted
Aug 19, 2025
Kind
B2
Abstract

Methods for rapid treatment of chronic migraine are provided. Exemplary methods provide relief from migraine within 24 hours of administration. Also provided are methods for acute treatment of migraine. Exemplary methods comprise administration of an anti-CGRP antagonist antibody to a patient in need thereof.

Claims (22)

1. A method of treating migraine, comprising administering an effective amount of an anti-calcitonin gene related peptide (CGRP) antibody to a patient, wherein said administering is by intravenous infusion and begins while the patient has a headache of a migraine attack and within 30 hours of the onset of said headache, and wherein the anti-CGRP antibody comprises: (a) a variable light chain polypeptide comprising the light chain complementarity-determining region (CDR) 1, 2, and 3 polypeptide sequences of SEQ ID NO: 224, SEQ ID NO: 226, and SEQ ID NO: 228, respectively; and (b) a variable heavy chain polypeptide comprising the heavy chain CDR 1, 2, and 3 polypeptide sequences of SEQ ID NO: 204, SEQ ID NO: 206, and SEQ ID NO: 208, respectively.

2. The method of claim 1 , wherein said administering begins within 18 hours, within 12 hours, within 6 hours, within 5 hours, within 4 hours, within 3 hours, within 2 hours, or within 1 hour of the onset of said headache.

3. The method of claim 1 , wherein said administering begins between about 1-6 hours from the start of said migraine attack.

4. The method of claim 1 , wherein said effective amount is: between about 100 mg and about 300 mg; or is about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, or about 300 mg.

5. The method of claim 1 , wherein: (a) the variable light chain polypeptide comprises the amino acid sequence of SEQ ID NO: 222; and (b) the variable heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO: 202.

6. The method of claim 1 , wherein said anti-CGRP antibody is an IgG molecule.

7. The method of claim 1 , wherein said anti-CGRP antibody comprises: (a) the light chain polypeptide of SEQ ID NO: 221; and (b) the heavy chain polypeptide of SEQ ID NO: 201 or SEQ ID NO: 566.

8. The method of claim 7 , wherein said anti-CGRP antibody consists of said light and heavy chain polypeptides.

9. The method of claim 1 , wherein said anti-CGRP antibody is expressed in or obtained by expression in: a yeast cell, optionally a Pichia pastoris cell; or a mammalian cell, optionally a CHO cell.

10. The method of claim 1 , wherein the anti-CGRP antibody is administered in a 0.9% sodium chloride solution, optionally 100 ml of a 0.9% sodium chloride solution.

11. The method of claim 1 , wherein said anti-CGRP antibody is an IgG1 molecule.

12. A method of treating migraine, comprising intravenously administering an effective amount of an anti-calcitonin gene related peptide (CGRP) antibody in a 0.9% sodium chloride solution to a patient, wherein said administering begins while the patient has a headache of a migraine attack and within 30 hours of the onset of said headache, and wherein the anti-CGRP antibody comprises: (a) a variable light chain polypeptide comprising the light chain complementarity-determining region (CDR) 1, 2, and 3 polypeptide sequences of SEQ ID NO: 224, SEQ ID NO: 226, and SEQ ID NO: 228, respectively; and (b) a variable heavy chain polypeptide comprising the heavy chain CDR 1, 2, and 3 polypeptide sequences of SEQ ID NO: 204, SEQ ID NO: 206, and SEQ ID NO: 208, respectively.

13. The method of claim 12 , wherein the anti-CGRP antibody is administered in 100 ml of a 0.9% sodium chloride solution.

14. The method of claim 12 , wherein said administering begins within 18 hours, within 12 hours, within 6 hours, within 5 hours, within 4 hours, within 3 hours, within 2 hours, or within 1 hour of the onset of said headache.

15. The method of claim 12 , wherein said administering begins between about 1-6 hours from the start of said migraine attack.

16. The method of claim 12 , wherein said effective amount is: between about 100 mg and about 300 mg; or is about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, or about 300 mg.

17. The method of claim 12 , wherein: (a) the variable light chain polypeptide comprises the amino acid sequence of SEQ ID NO: 222; and (b) the variable heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO: 202.

18. The method of claim 12 , wherein said anti-CGRP antibody is an IgG molecule.

19. The method of claim 12 , wherein said anti-CGRP antibody comprises: (a) the light chain polypeptide of SEQ ID NO: 221; and (b) the heavy chain polypeptide of SEQ ID NO: 201 or SEQ ID NO: 566.

20. The method of claim 19 , wherein said anti-CGRP antibody consists of said light and heavy chain polypeptides.

21. The method of claim 12 , wherein said anti-CGRP antibody is expressed in or obtained by expression in: a yeast cell, optionally a Pichia pastoris cell; or a mammalian cell, optionally a CHO cell.

22. The method of claim 12 , wherein said anti-CGRP antibody is an IgG1 molecule.

Continuity (5)
Division 16736925 · Jan 8, 2020
Provisional Application 62789828 · Jan 8, 2019
Provisional Application 62872989 · Jul 11, 2019
Provisional Application 62842162 · May 2, 2019
Related Publication 20240076359A1 · Mar 7, 2024
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