RU2017106756A - Композиция для контролируемой стимуляции яичников - Google Patents
Композиция для контролируемой стимуляции яичников Download PDFInfo
- Publication number
- RU2017106756A RU2017106756A RU2017106756A RU2017106756A RU2017106756A RU 2017106756 A RU2017106756 A RU 2017106756A RU 2017106756 A RU2017106756 A RU 2017106756A RU 2017106756 A RU2017106756 A RU 2017106756A RU 2017106756 A RU2017106756 A RU 2017106756A
- Authority
- RU
- Russia
- Prior art keywords
- patient
- sialylation
- product
- amh
- fsh
- Prior art date
Links
- 230000002611 ovarian Effects 0.000 title 1
- 230000000638 stimulation Effects 0.000 title 1
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 claims 12
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 claims 12
- 229940028334 follicle stimulating hormone Drugs 0.000 claims 12
- 210000002966 serum Anatomy 0.000 claims 9
- 230000009450 sialylation Effects 0.000 claims 9
- 230000037396 body weight Effects 0.000 claims 3
- 150000004676 glycans Chemical group 0.000 claims 3
- 208000000509 infertility Diseases 0.000 claims 3
- 230000036512 infertility Effects 0.000 claims 3
- 231100000535 infertility Toxicity 0.000 claims 3
- 229940088597 hormone Drugs 0.000 claims 2
- 239000005556 hormone Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 102000003864 Human Follicle Stimulating Hormone Human genes 0.000 claims 1
- 108010082302 Human Follicle Stimulating Hormone Proteins 0.000 claims 1
- 229910052783 alkali metal Inorganic materials 0.000 claims 1
- -1 alkali metal cation Chemical class 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
-
- 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
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Reproductive Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Claims (8)
1. Применение продукта, содержащего фолликулостимулирующий гормон (ФСГ), для лечения бесплодия у пациента, имеющего сывороточный уровень антимюллеровского гормона (АМГ) менее 15 пмоль/л, где продукт предназначен для введения в дозе, равной или эквивалентной 11-13 мкг рекомбинантного ФСГ человеческого происхождения в сутки, причем указанный рекомбинантный ФСГ включает α2,3- и α2,6-сиалирование, где от 1 до 50% общего сиалирования представляет собой α2,6-сиалирование и от 50 до 99% общего сиалирования представляет собой α2,3-сиалирование, и где лечение бесплодия включает стадию определения сывороточного уровня АМГ пациента и стадию введения указанной дозы пациенту, имеющему сывороточный уровень АМГ менее 15 пмоль/л.
2. Применение по п. 1, где продукт предназначен для введения в дозе, равной или эквивалентной 12 мкг рекомбинантного ФСГ в сутки.
3. Применение продукта, содержащего фолликулостимулирующий гормон (ФСГ), для лечения бесплодия у пациента, имеющего сывороточный уровень антимюллеровского гормона (АМГ) не менее 15 пмоль/л, где продукт предназначен для введения в дозе, равной или эквивалентной от 0,09 до 0,19 мкг рекомбинантного ФСГ человеческого происхождения на кг массы тела пациента в сутки, причем указанный рекомбинантный ФСГ включает α2,3- и α2,6-сиалирование, где от 1 до 50% общего сиалирования представляет собой α2,6-сиалирование и от 50 до 99% общего сиалирования представляет собой α2,3-сиалирование, и где лечение бесплодия включает стадию определения сывороточного уровня АМГ пациента и стадию введения указанной дозы пациенту, имеющему определенный сывороточный уровень АМГ.
4. Применение по п. 3 для лечения пациента, имеющего сывороточный уровень АМГ от 15 до 24,9 пмоль/л, где продукт предназначен для введения в дозе, равной или эквивалентной от 0,14 до 0,19 мкг рекомбинантного ФСГ на кг массы тела пациента в сутки.
5. Применение по п. 3 для лечения пациента, имеющего сывороточный уровень АМГ от 25 до 34,9 пмоль/л, где продукт предназначен для введения в дозе, равной или эквивалентной от 0,11 до 0,14 мкг рекомбинантного ФСГ на кг массы тела пациента в сутки.
6. Применение по п. 3 для лечения пациента, имеющего сывороточный уровень АМГ не менее 35 пмоль/л, где продукт предназначен для введения в дозе, равной или эквивалентной от 0,10 до 0,11 мкг рекомбинантного ФСГ человеческого происхождения на кг массы тела пациента в сутки.
7. Применение по любому из пп. 1-6, где ФСГ включает моно-, ди-, три- и тетра-сиалированные гликановые структуры, где 15-24%, например 17-23%, сиалированных гликановых структур составляют тетра-сиалированные гликановые структуры.
8. Применение по любому из пп. 1-7, где продукт дополнительно содержит соль, содержащую фармацевтически приемлемый катион щелочного металла, выбранную из группы, состоящей из солей Na+ или K+ или их комбинации.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11176803.2 | 2011-08-08 | ||
| EP11176803 | 2011-08-08 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014102924A Division RU2613324C3 (ru) | 2011-08-08 | 2012-08-08 | Композиция для контролируемой стимуляции яичников |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2020137769A Division RU2020137769A (ru) | 2020-11-18 | Композиция для контролируемой стимуляции яичников |
Publications (4)
| Publication Number | Publication Date |
|---|---|
| RU2017106756A true RU2017106756A (ru) | 2019-01-23 |
| RU2017106756A3 RU2017106756A3 (ru) | 2020-07-09 |
| RU2739037C2 RU2739037C2 (ru) | 2020-12-21 |
| RU2739037C3 RU2739037C3 (ru) | 2021-09-08 |
Family
ID=46785372
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017106756A RU2739037C3 (ru) | 2011-08-08 | 2012-08-08 | Композиция для контролируемой стимуляции яичников |
| RU2014102924A RU2613324C3 (ru) | 2011-08-08 | 2012-08-08 | Композиция для контролируемой стимуляции яичников |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014102924A RU2613324C3 (ru) | 2011-08-08 | 2012-08-08 | Композиция для контролируемой стимуляции яичников |
Country Status (31)
| Country | Link |
|---|---|
| US (4) | US9694052B2 (ru) |
| EP (9) | EP2821080B1 (ru) |
| JP (5) | JP6161609B2 (ru) |
| KR (7) | KR20200121918A (ru) |
| CN (2) | CN103732243A (ru) |
| AR (1) | AR087476A1 (ru) |
| AU (3) | AU2012293647B2 (ru) |
| BR (2) | BR112014002884A2 (ru) |
| CA (1) | CA2844282A1 (ru) |
| CY (1) | CY1117214T1 (ru) |
| DK (8) | DK3195875T3 (ru) |
| ES (7) | ES2704878T3 (ru) |
| FI (2) | FI3756681T3 (ru) |
| HK (2) | HK1204923A1 (ru) |
| HR (8) | HRP20240420T1 (ru) |
| HU (7) | HUE041769T2 (ru) |
| IL (2) | IL300380A (ru) |
| JO (1) | JO3092B1 (ru) |
| LT (7) | LT3566712T (ru) |
| MX (2) | MX348981B (ru) |
| PL (8) | PL2821080T3 (ru) |
| PT (6) | PT3756681T (ru) |
| RS (8) | RS65485B1 (ru) |
| RU (2) | RU2739037C3 (ru) |
| SA (1) | SA112330762B1 (ru) |
| SI (8) | SI3566712T1 (ru) |
| SM (1) | SMT201600038B (ru) |
| TR (2) | TR201900071T4 (ru) |
| TW (2) | TWI555530B (ru) |
| WO (1) | WO2013020996A1 (ru) |
| ZA (2) | ZA201400952B (ru) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
| TWI604850B (zh) * | 2009-10-05 | 2017-11-11 | 菲瑞茵國際中心股份有限公司 | 藥學製劑 |
| JO3092B1 (ar) | 2011-08-08 | 2017-03-15 | Ferring Bv | مركب لتحفيز مسيطر عليه للمبيض |
| CN107429237B (zh) * | 2014-12-22 | 2021-09-28 | 豪夫迈·罗氏有限公司 | Cmp依赖性的唾液酸酶活性 |
| US10660938B2 (en) * | 2015-04-17 | 2020-05-26 | Ferring B.V. | Recombinant FSH composition for treatment of infertility |
| RU2719468C2 (ru) | 2015-06-26 | 2020-04-17 | Ферринг Б.В. | Способы очистки и/или вирусной инактивации |
| BR112018003455A2 (pt) * | 2015-09-17 | 2018-09-25 | Glycotope Gmbh | composição ou composição farmacêutica e uso da composição |
| EP3518952A1 (en) | 2016-09-30 | 2019-08-07 | Myovant Sciences GmbH | Methods of treating female infertility |
| BR112020003379A2 (pt) | 2017-09-01 | 2020-08-25 | Ferring B.V. | usos de hormônio folículo-estimulante recombinante (fsh) para estimulação ovariana controlada |
| TW201945024A (zh) * | 2018-04-30 | 2019-12-01 | 荷蘭商菲林公司 | 用於經控制之卵巢刺激的組成物 |
| KR20210079276A (ko) | 2018-10-17 | 2021-06-29 | 훼링 비.브이. | 제어된 난소 자극을 위한 조성물 및 방법 |
| US11576920B2 (en) | 2019-03-18 | 2023-02-14 | The Menopause Method, Inc. | Composition and method to aid in hormone replacement therapy |
| CN110841060A (zh) * | 2019-11-21 | 2020-02-28 | 上海交通大学 | Choriogonadotropin alfa在治疗多囊卵巢综合征中的应用 |
| TW202237173A (zh) | 2020-12-09 | 2022-10-01 | 荷蘭商菲林公司 | 用於受控的卵巢刺激之組成物及方法 |
| WO2023186331A1 (en) | 2022-04-01 | 2023-10-05 | Ferring B.V. | Mixed protocol for treatment of infertility |
| WO2023227761A1 (en) | 2022-05-26 | 2023-11-30 | Ferring B.V. | Compositions and methods for treatment of infertility in males |
| WO2024008971A1 (en) | 2022-07-08 | 2024-01-11 | Ferring B.V. | Compositions and methods for intrauterine insemination (iui) |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL122732A0 (en) | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| EP1074265A1 (en) * | 1999-08-03 | 2001-02-07 | Erasmus Universiteit Rotterdam | Use of AMH and/or AMH agonists and/or AMH antagonists for long-term control of female fertility |
| CA2464368A1 (en) * | 2001-10-22 | 2003-05-01 | Applied Research Systems Ars Holding N.V. | Compositions of fsh with high sialylation degree and their use for the preparation of medicaments |
| US20040248784A1 (en) * | 2003-06-03 | 2004-12-09 | Marco Filicori | Unitary combinations of FSH and hCG |
| US8501719B2 (en) * | 2005-11-08 | 2013-08-06 | American Infertility Of New York | Androgen treatment in females |
| TWI488640B (zh) * | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
| TWI604850B (zh) * | 2009-10-05 | 2017-11-11 | 菲瑞茵國際中心股份有限公司 | 藥學製劑 |
| EP2417982A1 (en) | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilization of gonadotropins |
| WO2012016576A1 (en) * | 2010-08-04 | 2012-02-09 | Glycotope Gmbh | Improved recombinant human follicle-stimulating hormone |
| PL2621517T5 (pl) * | 2010-09-29 | 2024-01-29 | Ferring B.V. | Kompozycja do stosowania w leczeniu niepłodności |
| JO3092B1 (ar) | 2011-08-08 | 2017-03-15 | Ferring Bv | مركب لتحفيز مسيطر عليه للمبيض |
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