PL3409269T3 - Stabilizowane formulacje zawierające przeciwciała przeciwko receptorowi interleukiny 6 (IL-6R) - Google Patents
Stabilizowane formulacje zawierające przeciwciała przeciwko receptorowi interleukiny 6 (IL-6R)Info
- Publication number
- PL3409269T3 PL3409269T3 PL18174400T PL18174400T PL3409269T3 PL 3409269 T3 PL3409269 T3 PL 3409269T3 PL 18174400 T PL18174400 T PL 18174400T PL 18174400 T PL18174400 T PL 18174400T PL 3409269 T3 PL3409269 T3 PL 3409269T3
- Authority
- PL
- Poland
- Prior art keywords
- interleukin
- antibodies
- receptor
- formulations containing
- containing anti
- Prior art date
Links
Classifications
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- 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
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- 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
- 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
- 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
- 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
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
- C07K16/248—IL-6
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
- C07K2317/515—Complete light chain, i.e. VL + CL
-
- 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
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US29322710P | 2010-01-08 | 2010-01-08 | |
| US12/986,223 US9173880B2 (en) | 2010-01-08 | 2011-01-07 | Stabilized formulations containing anti-interleukin-6 receptor (IL-6R) antibodies |
| EP11703294.6A EP2521536B9 (en) | 2010-01-08 | 2011-01-07 | Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies |
| PCT/US2011/020457 WO2011085158A2 (en) | 2010-01-08 | 2011-01-07 | Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies |
| EP18174400.4A EP3409269B1 (en) | 2010-01-08 | 2011-01-07 | Stabilized formulations containing anti-interleukin-6 receptor (il-6r) antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL3409269T3 true PL3409269T3 (pl) | 2020-12-14 |
Family
ID=44258720
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL18174400T PL3409269T3 (pl) | 2010-01-08 | 2011-01-07 | Stabilizowane formulacje zawierające przeciwciała przeciwko receptorowi interleukiny 6 (IL-6R) |
| PL20184418.0T PL3756652T3 (pl) | 2010-01-08 | 2011-01-07 | Stabilizowane postacie użytkowe zawierające przeciwciała przeciwko receptorowi interleukiny 6 (il-6r) |
| PL11703294T PL2521536T3 (pl) | 2010-01-08 | 2011-01-07 | Stabilizowane formulacje zawierające przeciwciała receptora anty- interleukiny-6 (il-6r) |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL20184418.0T PL3756652T3 (pl) | 2010-01-08 | 2011-01-07 | Stabilizowane postacie użytkowe zawierające przeciwciała przeciwko receptorowi interleukiny 6 (il-6r) |
| PL11703294T PL2521536T3 (pl) | 2010-01-08 | 2011-01-07 | Stabilizowane formulacje zawierające przeciwciała receptora anty- interleukiny-6 (il-6r) |
Country Status (39)
| Country | Link |
|---|---|
| US (4) | US9173880B2 (pl) |
| EP (4) | EP3756652B1 (pl) |
| JP (2) | JP5805660B2 (pl) |
| KR (1) | KR101787351B1 (pl) |
| CN (1) | CN102869346B (pl) |
| AR (1) | AR079836A1 (pl) |
| AU (1) | AU2011204311B2 (pl) |
| BR (1) | BR112012016618A2 (pl) |
| CA (1) | CA2790197C (pl) |
| CL (1) | CL2012001853A1 (pl) |
| CO (1) | CO6592078A2 (pl) |
| CR (1) | CR20120393A (pl) |
| CY (2) | CY1121420T1 (pl) |
| DK (3) | DK3409269T3 (pl) |
| DO (1) | DOP2012000193A (pl) |
| EC (1) | ECSP12012092A (pl) |
| ES (3) | ES2925665T3 (pl) |
| GT (1) | GT201200223A (pl) |
| HR (3) | HRP20221139T1 (pl) |
| HU (3) | HUE051115T2 (pl) |
| JO (1) | JO3417B1 (pl) |
| LT (3) | LT2521536T (pl) |
| MA (1) | MA33993B1 (pl) |
| MX (1) | MX2012007794A (pl) |
| MY (1) | MY156702A (pl) |
| NI (1) | NI201200119A (pl) |
| NZ (1) | NZ601114A (pl) |
| PE (2) | PE20170948A1 (pl) |
| PL (3) | PL3409269T3 (pl) |
| PT (3) | PT2521536T (pl) |
| RS (3) | RS61045B1 (pl) |
| RU (1) | RU2554779C2 (pl) |
| SG (1) | SG182283A1 (pl) |
| SI (3) | SI2521536T1 (pl) |
| TW (2) | TWI533884B (pl) |
| UA (1) | UA107211C2 (pl) |
| UY (1) | UY33169A (pl) |
| WO (1) | WO2011085158A2 (pl) |
| ZA (1) | ZA201205035B (pl) |
Families Citing this family (82)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130064834A1 (en) | 2008-12-15 | 2013-03-14 | Regeneron Pharmaceuticals, Inc. | Methods for treating hypercholesterolemia using antibodies to pcsk9 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| AU2011301803A1 (en) | 2010-09-17 | 2013-03-21 | Baxalta GmbH | Stabilization of immunoglobulins and other proteins through aqueous formulations with sodium chloride at weak acidic to neutral pH |
| EP3733711A1 (en) | 2010-10-06 | 2020-11-04 | Regeneron Pharmaceuticals, Inc. | Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies |
| BR112013018740A2 (pt) | 2011-01-28 | 2019-01-08 | Sanofi Sa | anticorpos humanos para pcsk9 para uso em métodos de tratamento de grupos específicos de indivíduos |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CN103930444B (zh) | 2011-09-16 | 2020-08-04 | 瑞泽恩制药公司 | 用前蛋白转化酶枯草溶菌素-9(PCSK9)抑制剂降低脂蛋白(a)水平的方法 |
| KR20200039028A (ko) * | 2011-10-11 | 2020-04-14 | 사노피 바이오테크놀로지, 소시에떼 빠르 악씨옹 셍쁠리피에 | 류마티스 관절염 치료를 위한 조성물 및 이의 이용방법 |
| US9943594B2 (en) | 2011-10-11 | 2018-04-17 | Sanofi Biotechnology | Methods for the treatment of rheumatoid arthritis |
| TWI589299B (zh) * | 2011-10-11 | 2017-07-01 | 再生元醫藥公司 | 用於治療類風濕性關節炎之組成物及其使用方法 |
| JO3370B1 (ar) * | 2011-11-10 | 2019-03-13 | Regeneron Pharma | طريقة لتثبيط نمو الورم عن طريق تثبيط مستقبل انترلوكين 6 |
| CN105688188A (zh) | 2011-11-18 | 2016-06-22 | 瑞泽恩制药公司 | 聚合物蛋白微粒 |
| WO2013112438A1 (en) * | 2012-01-23 | 2013-08-01 | Regeneron Pharmaceuticals, Inc. | Stabilized formulations containing anti-ang2 antibodies |
| US9592289B2 (en) | 2012-03-26 | 2017-03-14 | Sanofi | Stable IgG4 based binding agent formulations |
| ES2702246T3 (es) * | 2012-03-26 | 2019-02-28 | Sanofi Sa | Formulaciones de agente de unión IgG4 estables |
| CN104768578A (zh) * | 2012-10-25 | 2015-07-08 | 米迪缪尼有限公司 | 稳定的低粘度抗体配制品 |
| RU2670943C9 (ru) | 2012-11-08 | 2018-11-26 | Илэвэн Байотерапьютикс, Инк. | Антагонисты ил-6 и их применение |
| AR095196A1 (es) | 2013-03-15 | 2015-09-30 | Regeneron Pharma | Medio de cultivo celular libre de suero |
| US10111953B2 (en) | 2013-05-30 | 2018-10-30 | Regeneron Pharmaceuticals, Inc. | Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9) |
| CA2914721A1 (en) | 2013-06-07 | 2014-12-11 | Regeneron Pharmaceuticals, Inc. | Methods for inhibiting atherosclerosis by administering an inhibitor of pcsk9 |
| TWI670077B (zh) | 2013-11-12 | 2019-09-01 | 賽諾菲生物技術公司 | 使用ｐｃｓｋ９抑制劑之給藥療程 |
| DE202014010499U1 (de) | 2013-12-17 | 2015-10-20 | Kymab Limited | Targeting von humaner PCSK9 zur Cholesterinbehandlung |
| US9017678B1 (en) | 2014-07-15 | 2015-04-28 | Kymab Limited | Method of treating rheumatoid arthritis using antibody to IL6R |
| WO2015116852A1 (en) | 2014-01-29 | 2015-08-06 | Regeneron Pharmaceuticals, Inc. | Methods for treating rheumatoid arthritis by administering an il-6r antibody |
| KR20170029613A (ko) | 2014-07-16 | 2017-03-15 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
| RS59805B1 (sr) | 2014-11-07 | 2020-02-28 | Sesen Bio Inc | Unapređena il-6 antitela |
| AR104847A1 (es) * | 2015-06-17 | 2017-08-16 | Lilly Co Eli | Formulación de anticuerpo anti-cgrp |
| TW202330904A (zh) | 2015-08-04 | 2023-08-01 | 美商再生元醫藥公司 | 補充牛磺酸之細胞培養基及用法 |
| EP3337828A1 (en) | 2015-08-18 | 2018-06-27 | Regeneron Pharmaceuticals, Inc. | Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis |
| MX2018010032A (es) * | 2016-02-23 | 2019-03-11 | Sesen Bio Inc | Formulaciones de antagonista de il-6 y sus usos. |
| MX2018010815A (es) * | 2016-03-07 | 2019-01-10 | Sanofi Biotechnology | Composiciones y metodos para tratar artritis reumatoide. |
| EP3216461A1 (en) | 2016-03-07 | 2017-09-13 | Sanofi Biotechnology | Compositions and methods for treating rheumatoid arthritis |
| EP3504328A1 (en) | 2016-08-24 | 2019-07-03 | Regeneron Pharmaceuticals, Inc. | Host cell protein modification |
| AU2017333367A1 (en) * | 2016-09-27 | 2019-04-04 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition |
| US11249082B2 (en) | 2016-10-29 | 2022-02-15 | University Of Miami | Zika virus assay systems |
| US20190324040A1 (en) * | 2016-10-29 | 2019-10-24 | University Of Miami | Zika virus antibodies |
| DK3532029T3 (da) | 2016-10-31 | 2021-06-07 | Fresenius Kabi Deutschland Gmbh | Flydende farmaceutisk sammensætning |
| EA201900326A1 (ru) * | 2016-12-23 | 2019-11-29 | Усовершенствованные способы повышения продуктивности антител в культурах клеток млекопитающих и сведения к минимуму агрегации в процессах выделения и очистки, получения композиций и стабильные композиции антител, полученные этими способами | |
| US11203636B2 (en) | 2017-02-01 | 2021-12-21 | Yale University | Treatment of existing left ventricular heart failure |
| WO2019010191A1 (en) | 2017-07-06 | 2019-01-10 | Regeneron Pharmaceuticals, Inc. | CELL CULTURE METHOD FOR PRODUCING GLYCOPROTEIN |
| EP3718531A4 (en) * | 2017-11-30 | 2023-08-16 | Bio-Thera Solutions, Ltd. | LIQUID PREPARATION OF A HUMANIZED ANTIBODY FOR THE TREATMENT OF IL-6-RELATED DISEASES |
| JP7321159B2 (ja) | 2017-12-22 | 2023-08-04 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 薬剤生成物不純物を特性決定するためのシステム及び方法 |
| KR20230047223A (ko) | 2018-01-05 | 2023-04-06 | 노보 노르디스크 에이/에스 | 면역억제 없이 il-6 매개 염증을 치료하기 위한 방법 |
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| MX2021009242A (es) | 2019-01-31 | 2021-10-26 | Sanofi Biotechnology | Anticuerpo anti-receptor de il-6 para tratar la artritis juvenil idiopatica. |
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