CR20220041A - Régimen de dosificación y administración para el tratamiento o prevención de enfermedades relacionadas con c5 mediante el uso del anticuerpo anti-c5 crovalimab - Google Patents
Régimen de dosificación y administración para el tratamiento o prevención de enfermedades relacionadas con c5 mediante el uso del anticuerpo anti-c5 crovalimabInfo
- Publication number
- CR20220041A CR20220041A CR20220041A CR20220041A CR20220041A CR 20220041 A CR20220041 A CR 20220041A CR 20220041 A CR20220041 A CR 20220041A CR 20220041 A CR20220041 A CR 20220041A CR 20220041 A CR20220041 A CR 20220041A
- Authority
- CR
- Costa Rica
- Prior art keywords
- antibody
- crovalimab
- dose
- dosage
- administration
- Prior art date
Links
Classifications
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
-
- 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
-
- 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
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- 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
- A61P7/06—Antianaemics
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
- A61K2039/507—Comprising a combination of two or more separate 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Transplantation (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Endocrinology (AREA)
- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Reproductive Health (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
La presente invención se relaciona con una dosis y régimen de administración de anticuerpos anti-C5, particularmente del anticuerpo anti-C5 Crovalimab, para usarse en un método de tratamiento o prevenir la enfermedad relacionada con C5 en un sujeto, que incluye hemoglobinuria nocturna paroxismal (PNH). El régimen de dosificación y tratamiento de la presente invención incluye la administración de un anticuerpo anti-C5, preferiblemente del anticuerpo anti-C5 Crovalimab, con dosis de carga seguido por la administración de (a) dosis de mantenimiento(s) del anticuerpo anti-C5 al sujeto, donde la dosis de carga administrada inicialmente es proporcionada intravenosamente al sujeto y la carga restante y las dosis de mantenimiento se administran subcutáneamente en una dosis baja como la dosis de carga administrada intravenosamente.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP19189442 | 2019-07-31 | ||
| EP20174790 | 2020-05-14 | ||
| EP20179591 | 2020-06-11 | ||
| PCT/EP2020/071555 WO2021019036A1 (en) | 2019-07-31 | 2020-07-30 | Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CR20220041A true CR20220041A (es) | 2022-03-02 |
Family
ID=71846415
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CR20220041A CR20220041A (es) | 2019-07-31 | 2020-07-30 | Régimen de dosificación y administración para el tratamiento o prevención de enfermedades relacionadas con c5 mediante el uso del anticuerpo anti-c5 crovalimab |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20220275070A1 (es) |
| EP (1) | EP4003409A1 (es) |
| JP (2) | JP7437261B2 (es) |
| KR (2) | KR20210016333A (es) |
| CN (2) | CN115068604A (es) |
| AU (1) | AU2020322165A1 (es) |
| CA (1) | CA3144923A1 (es) |
| CR (1) | CR20220041A (es) |
| IL (1) | IL288600B1 (es) |
| MX (1) | MX2022001154A (es) |
| TW (1) | TWI886140B (es) |
| WO (1) | WO2021019036A1 (es) |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL85035A0 (en) | 1987-01-08 | 1988-06-30 | Int Genetic Eng | Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same |
| WO1988007089A1 (en) | 1987-03-18 | 1988-09-22 | Medical Research Council | Altered antibodies |
| EP1400536A1 (en) | 1991-06-14 | 2004-03-24 | Genentech Inc. | Method for making humanized antibodies |
| AU691811B2 (en) | 1993-06-16 | 1998-05-28 | Celltech Therapeutics Limited | Antibodies |
| 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 |
| US6194551B1 (en) | 1998-04-02 | 2001-02-27 | Genentech, Inc. | Polypeptide variants |
| ES2292236T3 (es) | 1998-04-02 | 2008-03-01 | Genentech, Inc. | Variantes de anticuerpos y sus fragmentos. |
| US6737056B1 (en) | 1999-01-15 | 2004-05-18 | Genentech, Inc. | Polypeptide variants with altered effector function |
| HU230769B1 (hu) | 1999-01-15 | 2018-03-28 | Genentech Inc. | Módosított effektor-funkciójú polipeptid-változatok |
| AU2001296594A1 (en) | 2000-10-10 | 2002-04-22 | Tanox, Inc. | Inhibition of complement c5 activation for the treatment and prevention of delayed xenograft or acute vascular rejection |
| BRPI0211953B8 (pt) | 2001-08-17 | 2021-05-25 | Genentech Inc | anticorpo monoclonal ou fragmento de ligação a antígeno que se liga a c5 e c5a sem a prevenção da formação de c5b, linhagem celular, composição farmacêutica, bem como método in vitro para inibir a atividade de c5a e método de diagnóstico in vitro |
| ITMI20021527A1 (it) | 2002-07-11 | 2004-01-12 | Consiglio Nazionale Ricerche | Anticorpi anti componente c5 del complemento e loro uso |
| US7361740B2 (en) | 2002-10-15 | 2008-04-22 | Pdl Biopharma, Inc. | Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis |
| EP3263596A1 (en) | 2002-12-16 | 2018-01-03 | Genentech, Inc. | Immunoglobulin variants and uses thereof |
| US20070116710A1 (en) | 2004-02-03 | 2007-05-24 | Leonard Bell | Methods of treating hemolytic anemia |
| US20050169921A1 (en) | 2004-02-03 | 2005-08-04 | Leonard Bell | Method of treating hemolytic disease |
| KR100891620B1 (ko) | 2004-04-13 | 2009-04-02 | 에프. 호프만-라 로슈 아게 | 항-p-셀렉틴 항체 |
| TWI309240B (en) | 2004-09-17 | 2009-05-01 | Hoffmann La Roche | Anti-ox40l antibodies |
| PL3167888T3 (pl) | 2006-03-15 | 2024-08-26 | Alexion Pharmaceuticals, Inc. | Leczenie pacjentów z napadową nocną hemoglobinurią za pomocą inhibitora dopełniacza |
| PY09026846A (es) | 2008-08-05 | 2015-09-01 | Novartis Ag | Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5 |
| LT2894165T (lt) | 2008-11-10 | 2023-03-10 | Alexion Pharmaceuticals, Inc. | Būdai ir kompozicijos, skirti su komplementu susijusių sutrikimų gydymui |
| CN107207607B (zh) * | 2014-12-19 | 2021-05-04 | 中外制药株式会社 | 抗-c5抗体及使用方法 |
| IL259256B2 (en) | 2015-12-18 | 2023-02-01 | Chugai Pharmaceutical Co Ltd | Anti-c5 antibodies and methods of use |
| EP3402816A1 (en) | 2016-01-11 | 2018-11-21 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment |
| EP3408291A1 (en) | 2016-01-25 | 2018-12-05 | Shire Human Genetic Therapies, Inc. | Anti-c5 antibodies with enhanced ph switch |
| EP3554543A4 (en) * | 2016-12-16 | 2020-09-02 | Samsung Bioepis Co., Ltd. | STABLE Aqueous ANTI-C5 ANTIBODY COMPOSITION |
| IL307593A (en) | 2017-01-31 | 2023-12-01 | Chugai Pharmaceutical Co Ltd | A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease |
| CA3080187A1 (en) * | 2017-10-26 | 2019-05-02 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) |
-
2020
- 2020-07-30 CN CN202210578978.0A patent/CN115068604A/zh active Pending
- 2020-07-30 MX MX2022001154A patent/MX2022001154A/es unknown
- 2020-07-30 TW TW109125890A patent/TWI886140B/zh active
- 2020-07-30 KR KR1020207030736A patent/KR20210016333A/ko not_active Ceased
- 2020-07-30 CN CN202080054557.7A patent/CN114929273A/zh active Pending
- 2020-07-30 IL IL288600A patent/IL288600B1/en unknown
- 2020-07-30 US US17/630,046 patent/US20220275070A1/en active Pending
- 2020-07-30 KR KR1020247006223A patent/KR20240033090A/ko active Pending
- 2020-07-30 JP JP2020129462A patent/JP7437261B2/ja active Active
- 2020-07-30 WO PCT/EP2020/071555 patent/WO2021019036A1/en not_active Ceased
- 2020-07-30 EP EP20747415.6A patent/EP4003409A1/en active Pending
- 2020-07-30 CR CR20220041A patent/CR20220041A/es unknown
- 2020-07-30 CA CA3144923A patent/CA3144923A1/en active Pending
- 2020-07-30 AU AU2020322165A patent/AU2020322165A1/en active Pending
-
2022
- 2022-03-09 JP JP2022036164A patent/JP7748311B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CA3144923A1 (en) | 2021-02-04 |
| CN115068604A (zh) | 2022-09-20 |
| IL288600A (en) | 2022-02-01 |
| JP7437261B2 (ja) | 2024-02-22 |
| EP4003409A1 (en) | 2022-06-01 |
| TWI886140B (zh) | 2025-06-11 |
| CN114929273A (zh) | 2022-08-19 |
| TW202120125A (zh) | 2021-06-01 |
| MX2022001154A (es) | 2022-02-22 |
| AU2020322165A1 (en) | 2022-01-06 |
| IL288600B1 (en) | 2026-02-01 |
| JP2021038198A (ja) | 2021-03-11 |
| KR20210016333A (ko) | 2021-02-15 |
| WO2021019036A1 (en) | 2021-02-04 |
| KR20240033090A (ko) | 2024-03-12 |
| US20220275070A1 (en) | 2022-09-01 |
| JP2022101535A (ja) | 2022-07-06 |
| JP7748311B2 (ja) | 2025-10-02 |
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