CO2020004838A2 - Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua) - Google Patents
Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua)Info
- Publication number
- CO2020004838A2 CO2020004838A2 CONC2020/0004838A CO2020004838A CO2020004838A2 CO 2020004838 A2 CO2020004838 A2 CO 2020004838A2 CO 2020004838 A CO2020004838 A CO 2020004838A CO 2020004838 A2 CO2020004838 A2 CO 2020004838A2
- Authority
- CO
- Colombia
- Prior art keywords
- shua
- hpn
- antibodies
- dosage
- administration
- Prior art date
Links
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
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
- A61K2039/505—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
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Microbiology (AREA)
- Mycology (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)
Abstract
RESUMEN Se proporcionan métodos para el tratamiento clínico de la hemoglobinuria paroxística nocturna (HPN) y el síndrome hemolítico urémico atípico (SHUa) utilizando un anticuerpo anti-C5, o un fragmento de unión al antígeno del mismo.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762577244P | 2017-10-26 | 2017-10-26 | |
US201862643056P | 2018-03-14 | 2018-03-14 | |
US201862643608P | 2018-03-15 | 2018-03-15 | |
US201862662503P | 2018-04-25 | 2018-04-25 | |
US201862685425P | 2018-06-15 | 2018-06-15 | |
US201862685505P | 2018-06-15 | 2018-06-15 | |
PCT/US2018/057760 WO2019084438A1 (en) | 2017-10-26 | 2018-10-26 | ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS) |
Publications (1)
Publication Number | Publication Date |
---|---|
CO2020004838A2 true CO2020004838A2 (es) | 2020-05-29 |
Family
ID=64661436
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CONC2020/0004838A CO2020004838A2 (es) | 2017-10-26 | 2020-04-20 | Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua) |
Country Status (11)
Country | Link |
---|---|
US (1) | US20200254092A1 (es) |
EP (1) | EP3700928A1 (es) |
JP (2) | JP2021501134A (es) |
KR (1) | KR20200070355A (es) |
CN (1) | CN111868081A (es) |
AU (1) | AU2018354404A1 (es) |
BR (1) | BR112020008182A2 (es) |
CA (1) | CA3080187A1 (es) |
CO (1) | CO2020004838A2 (es) |
MX (1) | MX2020004284A (es) |
WO (1) | WO2019084438A1 (es) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11046784B2 (en) | 2006-03-31 | 2021-06-29 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
MX369784B (es) | 2007-09-26 | 2019-11-21 | Chugai Pharmaceutical Co Ltd | Metodo de modificacion del punto isoelectrico de anticuerpos mediante la sustitucion de aminoacidos en region de determinacion de complementariedad (cdr). |
DK2708559T3 (en) | 2008-04-11 | 2018-06-14 | Chugai Pharmaceutical Co Ltd | Antigen-binding molecule capable of repeatedly binding two or more antigen molecules |
CN108715614A (zh) | 2010-11-30 | 2018-10-30 | 中外制药株式会社 | 与多分子的抗原重复结合的抗原结合分子 |
LT3233921T (lt) | 2014-12-19 | 2021-12-10 | Chugai Seiyaku Kabushiki Kaisha | Anti-c5 antikūnai ir panaudojimo būdai |
EP4218813A3 (en) | 2017-07-27 | 2023-08-16 | Alexion Pharmaceuticals, Inc. | High concentration anti-c5 antibody formulations |
EP3802593A1 (en) * | 2018-05-31 | 2021-04-14 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients |
US20210332147A1 (en) * | 2018-06-04 | 2021-10-28 | Alexion Pharmaceuticals, Inc. | DOSAGE AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR TREATMENT OF ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) IN PEDIATRIC PATIENTS |
EP3829628B1 (en) * | 2018-08-01 | 2024-05-15 | Chugai Seiyaku Kabushiki Kaisha | A pharmaceutical composition for use in the treatment or prevention of a c5-related disease |
US20210395352A1 (en) * | 2018-10-30 | 2021-12-23 | Alexion Pharmaceuticals, Inc. | Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) |
CN113614105A (zh) * | 2019-01-25 | 2021-11-05 | 亚力兄制药公司 | 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用 |
MX2021009789A (es) * | 2019-02-14 | 2021-11-17 | Alexion Pharma Inc | Dosificacion y administracion de anticuerpos anti-c5 para el tratamiento de miastenia gravis generalizada. |
WO2020242849A1 (en) * | 2019-05-24 | 2020-12-03 | Alexion Pharmaceuticals, Inc. | Methods of treating vitiligo using an anti-c5 antibody |
CR20220040A (es) * | 2019-07-31 | 2022-03-02 | Hoffmann La Roche | Régimen de dosificación y administración para el tratamiento o prevención de enfermedades relacionadas con c5 mediante el uso del anticuerpo anti-c5 crovalimab |
WO2021019036A1 (en) * | 2019-07-31 | 2021-02-04 | F. Hoffmann-La Roche Ag | Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab |
KR20220047826A (ko) * | 2019-08-16 | 2022-04-19 | 리제너론 파마슈티칼스 인코포레이티드 | 고 농도의 항-c5 제형 |
EP4054634A1 (en) * | 2019-11-08 | 2022-09-14 | Alexion Pharmaceuticals, Inc. | High concentration anti-c5 antibody formulations |
US20230043576A1 (en) * | 2019-12-23 | 2023-02-09 | Alexion Pharmaceuticals, Inc. | Methods of treating pregnancy-associated atypical hemolytic uremic syndrome using an anti-c5 antibody |
US20210280304A1 (en) * | 2020-03-08 | 2021-09-09 | Gen LI | Integrated clinical trial design and design optimization |
WO2022036151A1 (en) * | 2020-08-13 | 2022-02-17 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) |
EP4232473A1 (en) * | 2020-10-23 | 2023-08-30 | Alexion Pharmaceuticals, Inc. | Methods of treating patients having complement disorders using anti-c5 antibodies |
WO2022265915A1 (en) * | 2021-06-14 | 2022-12-22 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treating dermatomyositis (dm) |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6074642A (en) | 1994-05-02 | 2000-06-13 | Alexion Pharmaceuticals, Inc. | Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis |
US8367805B2 (en) | 2004-11-12 | 2013-02-05 | Xencor, Inc. | Fc variants with altered binding to FcRn |
EP2815766B1 (en) | 2008-08-05 | 2017-07-05 | Novartis AG | Compositions and methods for antibodies targeting complement protein C5 |
US9382271B2 (en) | 2012-12-19 | 2016-07-05 | Promerus, Llc | Process for the preparation of high purity norbornene alkanols and derivatives thereof |
NZ631007A (en) | 2014-03-07 | 2015-10-30 | Alexion Pharma Inc | Anti-c5 antibodies having improved pharmacokinetics |
LT3233921T (lt) | 2014-12-19 | 2021-12-10 | Chugai Seiyaku Kabushiki Kaisha | Anti-c5 antikūnai ir panaudojimo būdai |
EP3402816A1 (en) * | 2016-01-11 | 2018-11-21 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment |
IL309975A (en) * | 2016-06-14 | 2024-03-01 | Regeneron Pharma | Antibodies against C5 and their uses |
KR20230043247A (ko) * | 2017-01-31 | 2023-03-30 | 추가이 세이야쿠 가부시키가이샤 | C5-관련 질환의 치료 또는 예방용 의약 조성물 및 c5-관련 질환을 치료 또는 예방하기 위한 방법 |
CN111683672A (zh) * | 2017-12-04 | 2020-09-18 | Ra制药公司 | 补体活性调节剂 |
-
2018
- 2018-10-26 CN CN201880083750.6A patent/CN111868081A/zh active Pending
- 2018-10-26 JP JP2020521452A patent/JP2021501134A/ja active Pending
- 2018-10-26 EP EP18815830.7A patent/EP3700928A1/en active Pending
- 2018-10-26 BR BR112020008182-5A patent/BR112020008182A2/pt unknown
- 2018-10-26 WO PCT/US2018/057760 patent/WO2019084438A1/en unknown
- 2018-10-26 CA CA3080187A patent/CA3080187A1/en active Pending
- 2018-10-26 MX MX2020004284A patent/MX2020004284A/es unknown
- 2018-10-26 US US16/757,512 patent/US20200254092A1/en active Pending
- 2018-10-26 KR KR1020207014525A patent/KR20200070355A/ko not_active Application Discontinuation
- 2018-10-26 AU AU2018354404A patent/AU2018354404A1/en active Pending
-
2020
- 2020-04-20 CO CONC2020/0004838A patent/CO2020004838A2/es unknown
-
2022
- 2022-10-26 JP JP2022171473A patent/JP2022186933A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
EP3700928A1 (en) | 2020-09-02 |
US20200254092A1 (en) | 2020-08-13 |
JP2022186933A (ja) | 2022-12-15 |
AU2018354404A1 (en) | 2020-04-16 |
BR112020008182A2 (pt) | 2020-10-27 |
KR20200070355A (ko) | 2020-06-17 |
CN111868081A (zh) | 2020-10-30 |
WO2019084438A1 (en) | 2019-05-02 |
JP2021501134A (ja) | 2021-01-14 |
CA3080187A1 (en) | 2019-05-02 |
MX2020004284A (es) | 2020-10-28 |
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