JP2018532728A - （持続性）外傷後頭痛の予防、治療および低減 - Google Patents

（持続性）外傷後頭痛の予防、治療および低減 Download PDF

Info

Publication number
JP2018532728A
JP2018532728A JP2018515658A JP2018515658A JP2018532728A JP 2018532728 A JP2018532728 A JP 2018532728A JP 2018515658 A JP2018515658 A JP 2018515658A JP 2018515658 A JP2018515658 A JP 2018515658A JP 2018532728 A JP2018532728 A JP 2018532728A
Authority
JP
Japan
Prior art keywords
antibody
monoclonal antibody
subject
administered
headache
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2018515658A
Other languages
English (en)
Japanese (ja)
Inventor
マルセロ ビガル
マルセロ ビガル
Original Assignee
テバ・ファーマシューティカルズ・インターナショナル・ゲー・エム・ベー・ハー
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テバ・ファーマシューティカルズ・インターナショナル・ゲー・エム・ベー・ハー filed Critical テバ・ファーマシューティカルズ・インターナショナル・ゲー・エム・ベー・ハー
Publication of JP2018532728A publication Critical patent/JP2018532728A/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2018515658A 2015-09-24 2016-09-23 （持続性）外傷後頭痛の予防、治療および低減 Pending JP2018532728A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562232343P 2015-09-24 2015-09-24
US62/232,343 2015-09-24
US201662375825P 2016-08-16 2016-08-16
US62/375,825 2016-08-16
PCT/IB2016/055720 WO2017051385A1 (en) 2015-09-24 2016-09-23 Preventing, treating, and reducing (persistent) post-traumatic headache

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019167098A Division JP2020002172A (ja) 2015-09-24 2019-09-13 （持続性）外傷後頭痛の予防、治療および低減

Publications (1)

Publication Number Publication Date
JP2018532728A true JP2018532728A (ja) 2018-11-08

Family

ID=57121460

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2018515658A Pending JP2018532728A (ja) 2015-09-24 2016-09-23 （持続性）外傷後頭痛の予防、治療および低減
JP2019167098A Pending JP2020002172A (ja) 2015-09-24 2019-09-13 （持続性）外傷後頭痛の予防、治療および低減

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2019167098A Pending JP2020002172A (ja) 2015-09-24 2019-09-13 （持続性）外傷後頭痛の予防、治療および低減

Country Status (13)

Country Link
US (3) US20170088612A1 (OSRAM)
EP (1) EP3353202B1 (OSRAM)
JP (2) JP2018532728A (OSRAM)
KR (2) KR20180058777A (OSRAM)
CN (1) CN108473560A (OSRAM)
AU (2) AU2016325738A1 (OSRAM)
CA (1) CA2999809A1 (OSRAM)
EA (1) EA201890578A1 (OSRAM)
ES (1) ES2846878T3 (OSRAM)
HK (1) HK1258385A1 (OSRAM)
IL (1) IL258008A (OSRAM)
MX (1) MX2018003713A (OSRAM)
WO (1) WO2017051385A1 (OSRAM)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103702685B (zh) 2011-05-20 2017-12-15 奥尔德生物控股有限责任公司 抗cgrp抗体和抗体片段用于在有需要的受试者、尤其是偏头痛患者中预防或抑制畏光或厌光的用途
TWI692485B (zh) 2011-05-20 2020-05-01 美商艾爾德生物控股有限責任公司 抗降血鈣素基因相關胜肽（ａｎｔｉ-ｃｇｒｐ）組成物及其用途
US20170114122A1 (en) 2015-10-23 2017-04-27 Alderbio Holdings Llc Regulation of glucose metabolism using anti-cgrp antibodies
US12168004B2 (en) 2014-02-05 2024-12-17 Merck Sharp & Dohme Llc Treatment of migraine
US11717515B2 (en) 2020-12-22 2023-08-08 Allergan Pharmaceuticals International Limited Treatment of migraine
CN112022818A (zh) 2014-02-05 2020-12-04 默沙东公司 Cgrp-活性化合物的片剂制剂
RS65360B1 (sr) 2014-03-21 2024-04-30 Teva Pharmaceuticals Int Gmbh Antagonistička antitela specifična za peptid genski srodan kalcitoninu i postupci njihove upotrebe
AU2017331593B2 (en) 2016-09-23 2022-04-28 Teva Pharmaceuticals International Gmbh Treating refractory migraine
US12398209B2 (en) * 2018-01-22 2025-08-26 Janssen Biotech, Inc. Methods of treating cancers with antagonistic anti-PD-1 antibodies
US12383545B1 (en) 2018-06-08 2025-08-12 Allergan Pharmaceuticals International Limited Treatment of migraine
US10899826B1 (en) 2018-09-13 2021-01-26 Teva Pharmaceuticals International Gmbh Pharmaceutical compositions for an anti-CGRP antagonist antibody
US11639380B2 (en) 2019-01-08 2023-05-02 H. Lundbeck A/S Acute treatment and rapid treatment of headache using anti-CGRP antibodies
CA3133912A1 (en) * 2019-04-18 2020-10-22 Allergan Sales, Llc Cgrp antagonists for the treatment of medication overuse headache, post-traumatic headache, post-concussion syndrome and vertigo
SG10202003296VA (en) 2020-04-06 2021-11-29 H Lundbeck As Treatment of most bothersome symptom (mbs) associated with migraine using anti-cgrp antibodies
CA3181130A1 (en) 2020-06-03 2021-12-09 William J. Binder Zonal and targeted methods and uses for treating a migraine disorder
EP4188375A4 (en) 2020-07-29 2024-07-24 Allergan Pharmaceuticals International Limited MIGRAINE TREATMENT
MX2024003952A (es) 2021-09-27 2024-05-27 Allergan Pharmaceuticals Int Ltd Combinación que comprende atogepant para tratar la migraña.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001526217A (ja) * 1997-12-19 2001-12-18 アストラゼネカ・アクチエボラーグ 血管性頭痛に対する局所麻酔薬の新規な使用
JP2009515942A (ja) * 2005-11-14 2009-04-16 ライナット ニューロサイエンス コーポレイション カルシトニン遺伝子関連ペプチドに対するアンタゴニスト抗体およびその使用方法
JP2015506174A (ja) * 2012-01-10 2015-03-02 ノクソン・ファルマ・アクチエンゲゼルシャフト Ｃｇｒｐに特異的に結合する核酸
JP2015509981A (ja) * 2012-05-23 2015-04-02 バインダー，ウイリアム，ジェイ． シナプス前部神経毒を用いた片頭痛の治療

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI692485B (zh) * 2011-05-20 2020-05-01 美商艾爾德生物控股有限責任公司 抗降血鈣素基因相關胜肽（ａｎｔｉ-ｃｇｒｐ）組成物及其用途

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001526217A (ja) * 1997-12-19 2001-12-18 アストラゼネカ・アクチエボラーグ 血管性頭痛に対する局所麻酔薬の新規な使用
JP2009515942A (ja) * 2005-11-14 2009-04-16 ライナット ニューロサイエンス コーポレイション カルシトニン遺伝子関連ペプチドに対するアンタゴニスト抗体およびその使用方法
JP2015506174A (ja) * 2012-01-10 2015-03-02 ノクソン・ファルマ・アクチエンゲゼルシャフト Ｃｇｒｐに特異的に結合する核酸
JP2015509981A (ja) * 2012-05-23 2015-04-02 バインダー，ウイリアム，ジェイ． シナプス前部神経毒を用いた片頭痛の治療

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, vol. 79, no. 6, JPN6019008701, January 2015 (2015-01-01), pages 886 - 895, ISSN: 0004202072 *
MABS, vol. 6, no. 4, JPN6019008700, 2014, pages 871 - 878, ISSN: 0004202073 *

Also Published As

Publication number Publication date
US20200148761A1 (en) 2020-05-14
IL258008A (en) 2018-06-28
CN108473560A (zh) 2018-08-31
WO2017051385A1 (en) 2017-03-30
ES2846878T3 (es) 2021-07-30
EP3353202B1 (en) 2020-11-04
KR20180058777A (ko) 2018-06-01
HK1258474A1 (en) 2019-11-15
JP2020002172A (ja) 2020-01-09
AU2016325738A1 (en) 2018-04-12
CA2999809A1 (en) 2017-03-30
HK1258385A1 (zh) 2019-11-08
KR20200035163A (ko) 2020-04-01
MX2018003713A (es) 2018-08-15
US20170088612A1 (en) 2017-03-30
EP3353202A1 (en) 2018-08-01
US20220048986A1 (en) 2022-02-17
EA201890578A1 (ru) 2018-12-28
AU2019261726A1 (en) 2019-11-28

Similar Documents

Publication Publication Date Title
US20220048986A1 (en) Preventing, treating, and reducing (persistent) post-traumatic headache
US11555064B2 (en) Treating headache comprising administering an antibody to calcitonin gene-related peptide
US20230235032A1 (en) Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same
JP2019530683A (ja) 難治性片頭痛の治療方法
CN103421114A (zh) 针对降钙素基因相关肽的拮抗剂抗体及其使用方法
HK40041381A (en) Antagonist antibodies directed against calcitonin gene-related peptide and methods using same
HK1258474B (en) Preventing, treating, and reducing (persistent) post-traumatic headache
BR122020017648B1 (pt) Composição para o tratamento ou redução da incidência de enxaqueca compreendendo um anticorpo monoclonal que inibe a via do peptídeo relacionado ao gene da calcitonina
HK1233955A1 (en) Antagonist antibodies directed against calcitonin gene-related peptide and methods using same

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180524

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180521

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180524

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190313

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20190605

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190913

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20200129