RU2016142273A - Фармацевтические композиции, содержащие антитела к pcsk9 человека - Google Patents
Фармацевтические композиции, содержащие антитела к pcsk9 человека Download PDFInfo
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Claims (22)
1. Фармацевтическая композиция, содержащая фиксированную дозу 75, 150 или 300 мг антитела или его антиген-связывающего фрагмента, которое специфически связывается с пропротеин конвертазой субтилизина/кексина типа 9 человека (hPCSK9), и фармацевтически приемлемый эксципиент или носитель, где антитело или его антигенсвязывающий фрагмент содержит аминокислотную последовательность вариабельной области тяжелой цепи (HCVR) и аминокислотную последовательность вариабельной области легкой цепи (LCVR), определенные в SEQ ID N0: 90 и 92, соответственно.
2. Фармацевтическая композиция по п. 1, содержащая фиксированную дозу 75 мг антитела или его антиген-связывающего фрагмента.
3. Фармацевтическая композиция по п. 1, содержащая фиксированную дозу 150 мг антитела или его антиген-связывающего фрагмента.
4. Фармацевтическая композиция по п. 1, содержащая фиксированную дозу 300 мг антитела или его антиген-связывающего фрагмента.
5. Фармацевтическая композиция по п. 1, где 1 мл раствора для инъекции содержит фиксированную дозу 75 мг, 150 мг, или 300 мг антитела или его антигенсвязывающего фрагмента.
6. Фармацевтическая композиция по п. 5, где раствор для инъекции содержит фиксированную дозу 75 мг антитела или его антигенсвязывающего фрагмента.
7. Фармацевтическая композиция по п. 5, где раствор для инъекции содержит фиксированную дозу 150 мг антитела или его антигенсвязывающего фрагмента.
8. Фармацевтическая композиция по п. 5, где раствор для инъекции содержит фиксированную дозу 300 мг антитела или его антигенсвязывающего фрагмента.
9. Фармацевтическая композиция по п. 1, представленная в виде лекарственной формы, где лекарственная форма содержит фиксированную дозу 75 мг, 150 мг или 300 мг антитела или его антиген-связывающего фрагмента.
10. Фармацевтическая композиция по п. 9, где лекарственная форма содержит фиксированную дозу 75 мг антитела или его антиген связывающего фрагмента.
11. Фармацевтическая композиция по п. 9, где лекарственная форма содержит фиксированную дозу 150 мг антитела или его антиген связывающего фрагмента.
12. Фармацевтическая композиция по п. 9, где лекарственная форма содержит фиксированную дозу 300 мг антитела или его антигенсвязывающего фрагмента.
13. Фармацевтическая композиция по п. 1, где фармацевтическая композиция находится в герметически закрытом контейнере, выбранном из группы, состоящей из флакона, саше, предварительно заполненного шприца или автоинъектора, картриджа для многоразового шприца и аппликатора.
14. Фармацевтическая композиция по п. 1, где антитело или его антигенсвязывающий фрагмент связывает эпитоп, содержащий один или несколько аминокислотных остатков в положениях 153, 159, 238 и 343 hPCSK9 (SEQ ID NO: 755).
15. Фармацевтическая композиция по п. 1, где антитело или его антигенсвязывающий фрагмент при введении субъекту обеспечивает одно или несколько из следующего:
снижение LDL-C от по меньшей мере 60% до по меньшей мере 75% относительно уровня до введения дозы с устойчивым снижением на протяжении периода по меньшей мере на 14 дней после введения субъекту дозы в 150 мг каждые две недели;
снижение LDL-C от по меньшей мере 50% до по меньшей мере 75% относительно уровня до введения дозы с устойчивым снижением на протяжении периода по меньшей мере на 28 дней после введения субъекту дозы в 300 мг каждые четыре недели;
увеличение уровня холестерина HDL в сыворотке по меньшей мере на 2%, по меньшей мере на 2,5%, по меньшей мере на 3%, по меньшей мере на 3,5%, по меньшей мере на 4%, по меньшей мере на 4,5%, по меньшей мере на 5% или по меньшей мере на 5,5% относительно уровня до введения дозы в 150 мг каждые две недели; и
снижение одного или нескольких из: уровней общего холестерина, уровней АроВ, уровней холестерина, не относящегося к IIDL-C, соотношения Аро-В/АроА-1.
16. Фармацевтическая композиция, содержащая фиксированную дозу 75 мг антитела или его антиген связывающего фрагмента, которое специфически связывается с hPCSK9, где антитело или его антиген-связывающий фрагмент содержит аминокислотную последовательность вариабельной области тяжелой цепи (HCVR) и аминокислотную последовательность вариабельной области легкой цепи (LCVR), определенные в SEQ ID NO: 90 и 92, соответственно, и где антитело или его антигенсвязывающий фрагмент находятся в 1 мл раствора для инъекции.
17. Фармацевтическая композиция, содержащая фиксированную дозу 150 мг антитела или его антиген-связывающего фрагмента, которое специфически связывается с hPCSK9, где антитело или его антигенсвязывающий фрагмент содержит аминокислотную последовательность вариабельной области тяжелой цепи (HCVR) и аминокислотную последовательность вариабельной области легкой цепи (LCVR), определенные в SEQ ID NO: 90 и 92, соответственно, и где антитело или его антигенсвязывающий фрагмент находится в 1 мл раствора для инъекции.
18. Фармацевтическая композиция, содержащая фиксированную дозу 300 мг антитела или его антигенсвязывающего фрагмента, которое специфически связывается с hPCSK9, где антитело или его антигенсвязывающий фрагмент содержит аминокислотную последовательность вариабельной области тяжелой цепи (HCVR) и аминокислотную последовательность вариабельной области легкой цепи (LCVR), определенные в SEQ ID NO: 90 и 92, соответственно, и где антитело или его антигенсвязывающий фрагмент находится в 1 мл раствора для инъекции.
Applications Claiming Priority (20)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11305089A EP2481758A1 (en) | 2011-01-28 | 2011-01-28 | Human antibodies to PSCK9 for use in methods of treating particular groups of subjects (11566) |
EP11305088.4 | 2011-01-28 | ||
EP11305088.4A EP2650016A1 (en) | 2011-01-28 | 2011-01-28 | Human antibodies to PSCK9 for use in methods of treatment based on particular dosage regimens (11565) |
EP11305089.2 | 2011-01-28 | ||
EP11305514.9 | 2011-04-29 | ||
EP11305513.1 | 2011-04-29 | ||
EP11305513 | 2011-04-29 | ||
EP11305514 | 2011-04-29 | ||
EP11306040 | 2011-08-12 | ||
EP11306039.6 | 2011-08-12 | ||
EP11306039 | 2011-08-12 | ||
EP11306040.4 | 2011-08-12 | ||
EP11306202 | 2011-09-22 | ||
EP11306201.2 | 2011-09-22 | ||
EP11306202.0 | 2011-09-22 | ||
EP11306201 | 2011-09-22 | ||
EP11306449.7 | 2011-11-08 | ||
EP11306450 | 2011-11-08 | ||
EP11306449 | 2011-11-08 | ||
EP11306450.5 | 2011-11-08 |
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RU2013139736/15A Division RU2604139C2 (ru) | 2011-01-28 | 2012-01-27 | Фармацевтические композиции, содержащие антитела к pcsk9 человека |
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RU2016142277A RU2721279C2 (ru) | 2011-01-28 | 2012-01-27 | Антитела человека к pcsk9 для применения в способах лечения конкретных групп индивидуумов |
RU2016142273A RU2016142273A (ru) | 2011-01-28 | 2012-01-27 | Фармацевтические композиции, содержащие антитела к pcsk9 человека |
RU2013139727/15A RU2603481C2 (ru) | 2011-01-28 | 2012-01-27 | Антитела человека к pcsk9 для применения в способах лечения конкретных групп индивидуумов |
RU2013139736/15A RU2604139C2 (ru) | 2011-01-28 | 2012-01-27 | Фармацевтические композиции, содержащие антитела к pcsk9 человека |
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RU2013139736/15A RU2604139C2 (ru) | 2011-01-28 | 2012-01-27 | Фармацевтические композиции, содержащие антитела к pcsk9 человека |
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2019
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