HRP20231255T1 - Režim doziranja anti-ifnar1 za potkožnu injekciju - Google Patents
Režim doziranja anti-ifnar1 za potkožnu injekciju Download PDFInfo
- Publication number
- HRP20231255T1 HRP20231255T1 HRP20231255TT HRP20231255T HRP20231255T1 HR P20231255 T1 HRP20231255 T1 HR P20231255T1 HR P20231255T T HRP20231255T T HR P20231255TT HR P20231255 T HRP20231255 T HR P20231255T HR P20231255 T1 HRP20231255 T1 HR P20231255T1
- Authority
- HR
- Croatia
- Prior art keywords
- unit dose
- disease
- use according
- ifnar1
- inhibitor
- Prior art date
Links
- 238000010254 subcutaneous injection Methods 0.000 title claims 2
- 239000007929 subcutaneous injection Substances 0.000 title claims 2
- 201000010099 disease Diseases 0.000 claims 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 11
- 101000852870 Homo sapiens Interferon alpha/beta receptor 1 Proteins 0.000 claims 4
- 102100036714 Interferon alpha/beta receptor 1 Human genes 0.000 claims 4
- 239000003112 inhibitor Substances 0.000 claims 4
- 208000005777 Lupus Nephritis Diseases 0.000 claims 2
- 208000004921 cutaneous lupus erythematosus Diseases 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 201000002481 Myositis Diseases 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- 229950010117 anifrolumab Drugs 0.000 claims 1
- 206010025135 lupus erythematosus Diseases 0.000 claims 1
- 230000001404 mediated effect Effects 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 230000003442 weekly effect Effects 0.000 claims 1
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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—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
-
- 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
- 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
- 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
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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
- C07K2317/90—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Transplantation (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Devices For Medical Bathing And Washing (AREA)
Claims (12)
1. Jedinična doza koja sadrži više od (>)105 mg i manje od (<)150 mg inhibitora tipa I IFN receptora (IFNAR1), pri čemu je inhibitor IFNAR1 anifrolumab i pri čemu je jedinična doza za potkožnu injekciju subjektu jednom tjedno (QW).
2. Jedinična doza prema zahtjevu 1, naznačena time što sadrži jednako ili manje od (≤)135 mg inhibitora IFNAR1.
3. Jedinična doza prema zahtjevu 1 ili 2, naznačena time što sadrži oko 120 mg inhibitora IFNAR1.
4. Jedinična doza prema bilo kojem od zahtjeva 1-3 za upotrebu u postupku liječenja ili prevencije bolesti kod subjekta, pri čemu upotreba uključuje potkožnu primjenu jedinične doze subjektu, pri čemu bolest je bolest posredovana interferonom tipa (IFN).
5. Jedinična doza za upotrebu prema zahtjevu 4, naznačena time što je bolest autoimuna bolest.
6. Jedinična doza za upotrebu prema zahtjevu 5, naznačena time što je bolest lupus.
7. Jedinična doza za upotrebu prema zahtjevu 6, naznačena time što je bolest SLE.
8. Jedinična doza za upotrebu prema zahtjevu 7, naznačena time što je bolest umjereni do teški, aktivni SLE pozitivan na autoprotutijela.
9. Jedinična doza za upotrebu prema zahtjevu 6, naznačena time što je bolest lupus nefritis (LN).
10. Jedinična doza za upotrebu prema zahtjevu 6, naznačena time što je bolest kožni eritematozni lupus (CLE).
11. Jedinična doza za upotrebu prema zahtjevu 5, naznačena time što je bolest miozitis.
12. Jedinična doza za upotrebu prema zahtjevu 5, naznačena time što je bolest sklerodermija.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163178739P | 2021-04-23 | 2021-04-23 | |
| US202163245285P | 2021-09-17 | 2021-09-17 | |
| US202163272851P | 2021-10-28 | 2021-10-28 | |
| PCT/EP2022/060592 WO2022223714A1 (en) | 2021-04-23 | 2022-04-21 | Anti-ifnar1 dosing regime for subcutaneous injection |
| EP22724683.2A EP4114465B1 (en) | 2021-04-23 | 2022-04-21 | Anti-ifnar1 dosing regime for subcutaneous injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231255T1 true HRP20231255T1 (hr) | 2024-02-02 |
Family
ID=81750490
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231255TT HRP20231255T1 (hr) | 2021-04-23 | 2022-04-21 | Režim doziranja anti-ifnar1 za potkožnu injekciju |
Country Status (23)
| Country | Link |
|---|---|
| US (2) | US20220340669A1 (hr) |
| EP (2) | EP4306541A3 (hr) |
| JP (2) | JP7484027B2 (hr) |
| KR (1) | KR20230166134A (hr) |
| AU (2) | AU2022260531B2 (hr) |
| BR (1) | BR112023021761A2 (hr) |
| CA (1) | CA3216387A1 (hr) |
| CL (1) | CL2023003114A1 (hr) |
| CO (1) | CO2023015498A2 (hr) |
| DK (1) | DK4114465T5 (hr) |
| ES (1) | ES2963757T3 (hr) |
| FI (1) | FI4114465T3 (hr) |
| HR (1) | HRP20231255T1 (hr) |
| HU (1) | HUE063562T2 (hr) |
| IL (1) | IL307748A (hr) |
| LT (1) | LT4114465T (hr) |
| MX (1) | MX2023012465A (hr) |
| PL (1) | PL4114465T3 (hr) |
| PT (1) | PT4114465T (hr) |
| RS (1) | RS64821B1 (hr) |
| SI (1) | SI4114465T1 (hr) |
| TW (1) | TW202317182A (hr) |
| WO (1) | WO2022223714A1 (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4306541A3 (en) | 2021-04-23 | 2024-03-27 | Astrazeneca AB | Anti-ifnar1 dosing regime for subcutaneous injection |
| CN113621063A (zh) * | 2021-08-02 | 2021-11-09 | 江苏荃信生物医药有限公司 | 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002098370A2 (en) | 2001-03-02 | 2002-12-12 | Medimmune, Inc. | Methods of administering/dosing cd2 antagonists for the prevention and treatment of autoimmune disorders or inflammatory disorders |
| US20040037809A1 (en) | 2002-06-28 | 2004-02-26 | Nastech Pharmaceutical Company Inc. | Compositions and methods for enhanced mucosal delivery of interferon beta |
| PL1711207T3 (pl) | 2003-12-10 | 2013-08-30 | Squibb & Sons Llc | Przeciwciała przeciwko interferonowi alfa i ich zastosowania |
| CN102863532A (zh) * | 2004-06-21 | 2013-01-09 | 米德列斯公司 | 干扰素α受体1抗体及其用途 |
| EP1907858A4 (en) | 2005-06-13 | 2009-04-08 | Univ Michigan | COMPOSITIONS AND METHODS OF TREATMENT AND DIAGNOSIS OF CANCER |
| CA2651866C (en) | 2006-05-11 | 2014-10-28 | Universiteit Gent | Sialoadhesin-related compositions and methods |
| KR20090088932A (ko) | 2006-12-06 | 2009-08-20 | 메디뮨 엘엘씨 | 전신 홍반성 낭창의 치료 방법 |
| ES2567094T3 (es) | 2007-07-12 | 2016-04-19 | The Brigham And Women's Hospital, Inc. | Composiciones y métodos para diagnosticar y evaluar las miopatías inflamatorias |
| RU2530561C2 (ru) | 2007-11-05 | 2014-10-10 | Медиммун, Ллк | Способы лечения склеродермии |
| PL2250279T3 (pl) | 2008-02-08 | 2016-11-30 | Przeciwciała anty-ifnar1 o zmniejszonym powinowactwie do liganda fc | |
| US20110287022A1 (en) | 2008-06-20 | 2011-11-24 | Medlmmune, Llc | Interferon alpha-induced pharmacodynamic markers |
| BRPI0917871A2 (pt) | 2008-08-15 | 2017-06-20 | Merrimack Pharmaceuticals Inc | agente terapêutico anti-erbb3 para uso em terapia de um tumor, métodos para predizer responsividade de um tumor de um agente terapêutco anti-erbb3, para selecionar terapia anti-erbb3 para um paciente, para predizer a resposta de células ao tratamento com um agente terapêutico, para identificar um biomarcador, e para evitar administração de uma droga para câncer anti-erbb3, e, kit para predizer a resposta das células ao tratamento com um agente terapêutico |
| CN102753704A (zh) | 2009-09-03 | 2012-10-24 | 米迪缪尼有限公司 | I型干扰素诊断 |
| JP2015526391A (ja) | 2012-06-13 | 2015-09-10 | メディミューン，エルエルシー | 抗ｉ型インターフェロン受容体（ｉｆｎａｒ）抗体のための固定用量レジメン |
| SG10202106970XA (en) | 2015-08-19 | 2021-07-29 | Astrazeneca Ab | Stable anti-ifnar1 formulation |
| CN106243226B (zh) | 2016-08-05 | 2019-02-12 | 北京智仁美博生物科技有限公司 | 抗人ifnar1的抗体及其用途 |
| EA202190378A1 (ru) * | 2018-09-18 | 2021-09-06 | Ай-Маб Биофарма (Ханчжоу) Ко., Лтд. | Антитела против ifnar1 для лечения аутоиммунных заболеваний |
| MA54937A (fr) | 2019-02-15 | 2021-12-22 | Astrazeneca Ab | Troubles induits par l'interféron de type i |
| KR20220099985A (ko) | 2019-11-11 | 2022-07-14 | 아스트라제네카 아베 | 전신성 홍반성 루푸스에서 i형 인터페론 억제 |
| KR20230018446A (ko) | 2020-05-29 | 2023-02-07 | 아스트라제네카 아베 | I형 인터페론 신호전달 억제제를 이용한 심장대사 질환의 치료 |
| TW202237647A (zh) * | 2020-10-08 | 2022-10-01 | 瑞典商阿斯特捷利康公司 | 狼瘡發作之治療 |
| EP4247423A2 (en) * | 2020-11-18 | 2023-09-27 | Astrazeneca AB | Steroid sparing |
| US20220348669A1 (en) | 2021-04-23 | 2022-11-03 | Astrazeneca Ab | Treatment of lupus nephritis |
| EP4306541A3 (en) | 2021-04-23 | 2024-03-27 | Astrazeneca AB | Anti-ifnar1 dosing regime for subcutaneous injection |
| CN113278070B (zh) | 2021-04-25 | 2022-06-14 | 福州迈新生物技术开发有限公司 | 抗ck17蛋白单克隆抗体及其细胞株、制备方法和应用 |
| CN113521276B (zh) * | 2021-07-13 | 2022-04-12 | 江苏荃信生物医药股份有限公司 | 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂 |
-
2022
- 2022-04-21 EP EP23186947.0A patent/EP4306541A3/en active Pending
- 2022-04-21 LT LTEPPCT/EP2022/060592T patent/LT4114465T/lt unknown
- 2022-04-21 ES ES22724683T patent/ES2963757T3/es active Active
- 2022-04-21 AU AU2022260531A patent/AU2022260531B2/en active Active
- 2022-04-21 EP EP22724683.2A patent/EP4114465B1/en active Active
- 2022-04-21 WO PCT/EP2022/060592 patent/WO2022223714A1/en active Application Filing
- 2022-04-21 HU HUE22724683A patent/HUE063562T2/hu unknown
- 2022-04-21 KR KR1020237039588A patent/KR20230166134A/ko not_active Application Discontinuation
- 2022-04-21 BR BR112023021761A patent/BR112023021761A2/pt unknown
- 2022-04-21 JP JP2023562678A patent/JP7484027B2/ja active Active
- 2022-04-21 PL PL22724683.2T patent/PL4114465T3/pl unknown
- 2022-04-21 SI SI202230007T patent/SI4114465T1/sl unknown
- 2022-04-21 HR HRP20231255TT patent/HRP20231255T1/hr unknown
- 2022-04-21 RS RS20230991A patent/RS64821B1/sr unknown
- 2022-04-21 IL IL307748A patent/IL307748A/en unknown
- 2022-04-21 CA CA3216387A patent/CA3216387A1/en active Pending
- 2022-04-21 MX MX2023012465A patent/MX2023012465A/es unknown
- 2022-04-21 PT PT227246832T patent/PT4114465T/pt unknown
- 2022-04-21 FI FIEP22724683.2T patent/FI4114465T3/fi active
- 2022-04-21 DK DK22724683.2T patent/DK4114465T5/da active
- 2022-04-22 TW TW111115445A patent/TW202317182A/zh unknown
- 2022-04-22 US US17/660,317 patent/US20220340669A1/en active Pending
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2023
- 2023-04-21 US US18/305,235 patent/US12060429B2/en active Active
- 2023-10-19 CL CL2023003114A patent/CL2023003114A1/es unknown
- 2023-11-16 CO CONC2023/0015498A patent/CO2023015498A2/es unknown
-
2024
- 2024-03-18 AU AU2024201743A patent/AU2024201743A1/en active Pending
- 2024-05-01 JP JP2024074264A patent/JP2024102205A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| PL4114465T3 (pl) | 2024-04-08 |
| EP4306541A2 (en) | 2024-01-17 |
| ES2963757T3 (es) | 2024-04-01 |
| WO2022223714A1 (en) | 2022-10-27 |
| KR20230166134A (ko) | 2023-12-06 |
| RS64821B1 (sr) | 2023-12-29 |
| LT4114465T (lt) | 2023-11-10 |
| HUE063562T2 (hu) | 2024-01-28 |
| DK4114465T3 (da) | 2023-10-30 |
| JP7484027B2 (ja) | 2024-05-15 |
| PT4114465T (pt) | 2023-11-03 |
| CL2023003114A1 (es) | 2024-04-19 |
| EP4114465A1 (en) | 2023-01-11 |
| MX2023012465A (es) | 2024-04-04 |
| BR112023021761A2 (pt) | 2023-12-26 |
| CA3216387A1 (en) | 2022-10-27 |
| EP4114465B1 (en) | 2023-08-30 |
| AU2022260531A9 (en) | 2023-12-07 |
| AU2024201743A1 (en) | 2024-04-04 |
| IL307748A (en) | 2023-12-01 |
| US20230365698A1 (en) | 2023-11-16 |
| TW202317182A (zh) | 2023-05-01 |
| AU2022260531B2 (en) | 2024-03-07 |
| DK4114465T5 (da) | 2024-07-22 |
| US20220340669A1 (en) | 2022-10-27 |
| FI4114465T3 (fi) | 2023-10-31 |
| EP4306541A3 (en) | 2024-03-27 |
| JP2024102205A (ja) | 2024-07-30 |
| US12060429B2 (en) | 2024-08-13 |
| CO2023015498A2 (es) | 2023-11-30 |
| JP2024511227A (ja) | 2024-03-12 |
| AU2022260531A1 (en) | 2023-11-30 |
| SI4114465T1 (sl) | 2023-11-30 |
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| Richardson | The Newton Cotes coefficients in APL | |
| Maruri et al. | A rare case of Mauriac neuralgic genital herpes. | |
| Strand | Selective T-cell costimulation modulation: a new approach to treating rheumatoid arthritis | |
| McGaugh et al. | Analysis of Neural Systems Involved in Modulation of Memory Storage |