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NZ761634B2 - Combination therapy of lasmiditan and a cgrp antagonist for use in the treatment of migraine - Google Patents
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NZ761634B2 - Combination therapy of lasmiditan and a cgrp antagonist for use in the treatment of migraine - Google Patents

Combination therapy of lasmiditan and a cgrp antagonist for use in the treatment of migraine Download PDF

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Publication number
NZ761634B2
NZ761634B2 NZ761634A NZ76163418A NZ761634B2 NZ 761634 B2 NZ761634 B2 NZ 761634B2 NZ 761634 A NZ761634 A NZ 761634A NZ 76163418 A NZ76163418 A NZ 76163418A NZ 761634 B2 NZ761634 B2 NZ 761634B2
Authority
NZ
New Zealand
Prior art keywords
medicament
migraine
lasmiditan
treatment
administered
Prior art date
Application number
NZ761634A
Other versions
NZ761634A (en
Inventor
Sheena Aurora
Kirk Willis Johnson
John Henry Krege
Original Assignee
Eli Lilly And Company
Filing date
Publication date
Application filed by Eli Lilly And Company filed Critical Eli Lilly And Company
Priority claimed from PCT/US2018/048730 external-priority patent/WO2019050759A1/en
Publication of NZ761634A publication Critical patent/NZ761634A/en
Publication of NZ761634B2 publication Critical patent/NZ761634B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

The present invention relates to combinations of lasmiditan and a calcitonin gene-related peptide (CGRP) antagonist, for example the combination of lasmiditan and galcanezumab, and to methods of using the combinations for treatment of migraine, particularly migraine inadequately controlled by lasmiditan or a CGRP antagonist therapy alone, and more particularly, to treat therapy resistant migraine which is defined herein as migraine refractory to two or more prior monotherapy and/or dual therapy treatment regimens.

Claims (13)

What is claimed:
1. Use of lasmiditan in the manufacture of a medicament for the treatment of migraine in a patient, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with a calcitonin gene-related 5 peptide (CGRP) antagonist.
2. Use of a calcitonin gene-related peptide (CGRP) antagonist in the manufacture of a medicament for the treatment of migraine in a patient, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with lasmitidan. 10
3. Use of lasmiditan in the manufacture of a medicament for the treatment of migraine in a patient, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with galcanezumab.
4. Use of galcanezumab in the manufacture of a medicament for the treatment of migraine in a patient, wherein the medicament is to be administered in 15 simultaneous, separate, or sequential combination with lasmitidan.
5. Use of lasmiditan in the manufacture of a medicament for the treatment of migraine in a patient inadequately controlled by lasmiditan or a CGRP antagonist therapy alone, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with a calcitonin gene-related peptide (CGRP) 20 antagonist.
6. Use of a calcitonin gene-related peptide (CGRP) antagonist in the manufacture of a medicament for the treatment of migraine in a patient inadequately controlled by lasmiditan or a CGRP antagonist therapy alone, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with 25 lasmiditan.
7. Use of lasmiditan in the manufacture of a medicament for the treatment of migraine in a patient inadequately controlled by lasmiditan or a CGRP antagonist therapy alone, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with galcanezumab.
8. Use of galcanezumab in the manufacture of a medicament for the treatment of migraine in a patient inadequately controlled by lasmiditan or a CGRP antagonist 5 therapy alone, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with lasmiditan.
9. Use of lasmiditan in the manufacture of a medicament for the treatment of migraine in a patient suffering from therapy resistant migraine wherein the patients migraines have been refractory to two or more prior monotherapy and/or 10 dual therapy treatment regimens, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with a calcitonin gene-related peptide (CGRP) antagonist.
10. Use of a calcitonin gene-related peptide (CGRP) antagonist in the manufacture of a medicament for the treatment of migraine in a patient suffering from therapy 15 resistant migraine wherein the patients migraines have been refractory to two or more prior monotherapy and/or dual therapy treatment regimens, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with lasmiditan.
11. Use of lasmiditan in in the manufacture of a medicament for the treatment of 20 migraine in a patient suffering from therapy resistant migraine wherein the patients migraines have been refractory to two or more prior monotherapy and/or dual therapy treatment regimens, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with galcanezumab.
12. Use of galcanezumab in in the manufacture of a medicament for the treatment of 25 migraine in a patient suffering from therapy resistant migraine wherein the patients migraines have been refractory to two or more prior monotherapy and/or dual therapy treatment regimens, wherein the medicament is to be administered in simultaneous, separate, or sequential combination with lasmiditan.
13. A use of any one of claims 3, 4, 7, 8, 11 or 12, wherein the treatment comprises administration of galcanezumab in an initial loading dose of 240 mg of followed by a monthly maintenance dose of
NZ761634A 2018-08-30 Combination therapy of lasmiditan and a cgrp antagonist for use in the treatment of migraine NZ761634B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762554726P 2017-09-06 2017-09-06
PCT/US2018/048730 WO2019050759A1 (en) 2017-09-06 2018-08-30 Combination therapy of lasmiditan and a cgrp antagonist for use in the treatment of migraine

Publications (2)

Publication Number Publication Date
NZ761634A NZ761634A (en) 2024-05-31
NZ761634B2 true NZ761634B2 (en) 2024-09-03

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