# US 12,215,145 B2 · Treatment of headache using anti-CGRP antibodies > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,215,145 B2 - Document ID: US12215145B2 - Status: Granted - Kind: B2 - Application number: 18/609,247 - Filed: 2024-03-19 - Published: 2024-07-18 - Granted: 2025-02-04 - Earliest claimed: 2019-01-08 - Assignees: H. Lundbeck A/S - Applicants: H. Lundbeck A/S - Inventors: Roger K. Cady; Jeffrey T. L. Smith; Joseph Hirman; Barbara Schaeffler; Lahar Mehta - Web page: https://patentgrep.com/patent/US12215145B2 ## CPC - C07K 16/18: against material from animals or humans - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 31/4172: Imidazole-alkanecarboxylic acids, e.g. histidine - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61P 25/06: Antimigraine agents - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - A61K 2039/505: {comprising antibodies} - A61K 2039/54: {characterised by the route of administration} - A61K 2039/545: {characterised by the dose, timing or administration schedule} - C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/41: Glycosylation, sialylation, or fucosylation - C07K 2317/526: CH3 domain - C07K 2317/565: Complementarity determining region [CDR] - C07K 2317/71: Decreased effector function due to an Fc-modification - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Methods for immediate relief of migraine or headache are provided comprising the administration of an anti-CGRP antagonist antibody to a patient in need thereof. ## Claims ### Claim 1 A method of treating migraine in a patient in need thereof, the method comprising intravenously administering to the patient a humanized monoclonal antibody comprising: (A) a variable light chain polypeptide comprising light chain complementary 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 heavy chain CDR 1, 2, and 3 polypeptide sequences of SEQ ID NO: 204, SEQ ID NO: 206, and SEQ ID NO: 208, respectively, wherein the humanized monoclonal antibody is administered to the patient at a dose of about 100 mg, the administration begins while the patient is experiencing a migraine attack, and the prevention of one or more symptoms is experienced by the patient within a short time period post-infusion with said antibody, such as within minutes or a few hours, such as within 10 minutes, 20 minutes, 30 minutes, 60 minutes, 1 hour, 2 hours or 6 hours. ### Claim 2 (depends on 1) The method according to claim 1, wherein the humanized monoclonal antibody comprises a human IgG1 constant region and is produced in CHO cells or Pichia pastoris yeast cells. ### Claim 3 (depends on 1) The method according to claim 1, wherein the humanized monoclonal antibody is a humanized IgG1 monoclonal antibody. ### Claim 4 (depends on 1) The method according to claim 1, wherein: (A) the variable light chain polypeptide comprises the amino acid sequence of SEQ ID NO: 222; and/or (B) the variable heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO: 202. ### Claim 5 (depends on 4) The method according to claim 4, wherein the humanized monoclonal antibody is produced in CHO cells. ### Claim 6 (depends on 5) The method according to claim 5, wherein the humanized monoclonal antibody further comprises a heavy chain constant region polypeptide comprising the amino acid sequence of SEQ ID NO: 565. ### Claim 7 (depends on 1) The method according to claim 1, wherein the humanized monoclonal antibody comprises: (A) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 221; and (B) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 201 or 566. ### Claim 8 (depends on 1) The method according to claim 1, wherein the humanized monoclonal antibody comprises: (A) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 221; and (B) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 201 or 566. ### Claim 9 (depends on 1) The method according to claim 1, wherein the patient suffers from chronic migraine. ### Claim 10 (depends on 1) The method according to claim 1, wherein the patient suffers from episodic migraine. ### Claim 11 (depends on 8) The method according to claim 8, wherein the patient experiences a reduction in migraine prevalence on the first day following the day of being administered the humanized monoclonal antibody, relative to the migraine prevalence experienced by the patient on the day prior to said administration. ### Claim 12 (depends on 1) The method according to claim 1, wherein the humanized monoclonal antibody is intravenously administered to the patient while the patient is experiencing a migraine attack that comprises headache pain of moderate to severe intensity. ### Claim 13 (depends on 1) The method according to claim 1, wherein the patient experiences relief from migraine within about four hours following the intravenous administration of the humanized monoclonal antibody. ### Claim 14 (depends on 13) The method according to claim 13, wherein: (i) said relief from migraine comprises a reduction of headache pain; (ii) the patient reaches headache pain freedom within about four hours following the intravenous administration of the humanized monoclonal antibody; (iii) the patient reaches headache pain freedom within about two hours following the intravenous administration of the humanized monoclonal antibody; and/or (iv) said relief from migraine comprises a reduction in the most bothersome symptom, and wherein the patient experiences said reduction in the most bothersome symptom within about two hours following the intravenous administration of the humanized monoclonal antibody. ### Claim 15 (depends on 13) The method according to claim 13, wherein the patient suffers from chronic migraine. ### Claim 16 (depends on 13) The method according to claim 13, wherein the patient suffers from episodic migraine. ### Claim 17 (depends on 1) The method according to claim 1, wherein the one or more symptoms comprise photophobia, phonophobia, and/or nausea. ### Claim 18 (depends on 1) The method according to claim 1, wherein said administering performed while the patient is experiencing photophobia, phonophobia, and/or nausea. ### Claim 19 A method of providing acute treatment of migraine in a patient in need thereof, the method comprising intravenously administering to the patient about 100 mg of a humanized monoclonal antibody comprising: (A) a variable light chain polypeptide comprising light chain complementary 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 heavy chain CDR 1, 2, and 3 polypeptide sequences of SEQ ID NO: 204, SEQ ID NO: 206, and SEQ ID NO: 208, respectively, wherein the administration of the humanized monoclonal antibody begins while the patient is experiencing a migraine attack, and wherein said acute treatment of migraine comprises a reduction in headache pain within about four hours following the intravenous administration of the humanized monoclonal antibody. ### Claim 20 (depends on 19) The method according to claim 19, wherein the humanized monoclonal antibody is intravenously administered to the patient while the patient is experiencing headache pain of moderate to severe intensity. ### Claim 21 (depends on 19) The method according to claim 19, wherein the humanized monoclonal antibody is intravenously administered to the patient over a time period of approximately 30 minutes. ### Claim 22 (depends on 19) The method according to claim 19, wherein said acute treatment of migraine comprises a reduction in headache pain within about two hours following the intravenous administration of the humanized monoclonal antibody. ### Claim 23 (depends on 19) The method according to claim 19, wherein the humanized monoclonal antibody comprises a human lgG1 constant region and is produced in CHO cells or Pichia pastoris yeast cells. ### Claim 24 (depends on 19) The method according to claim 19, wherein the humanized monoclonal antibody is a humanized IgG1 monoclonal antibody. ### Claim 25 (depends on 19) The method according to claim 19, wherein: (A) the variable light chain polypeptide comprises the amino acid sequence of SEQ ID NO: 222; and/or (B) the variable heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO: 202. ### Claim 26 (depends on 25) The method according to claim 25, wherein the humanized monoclonal antibody is produced in CHO cells. ### Claim 27 (depends on 25) The method according to claim 25, wherein the humanized monoclonal antibody further comprises a heavy chain constant region polypeptide comprising the amino acid sequence of SEQ ID NO: 565. ### Claim 28 (depends on 19) The method according to claim 19, wherein the humanized monoclonal antibody comprises: (A) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 221; and (B) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 201 or 566.