JP2014508142A5 - - Google Patents
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- JP2014508142A5 JP2014508142A5 JP2013550892A JP2013550892A JP2014508142A5 JP 2014508142 A5 JP2014508142 A5 JP 2014508142A5 JP 2013550892 A JP2013550892 A JP 2013550892A JP 2013550892 A JP2013550892 A JP 2013550892A JP 2014508142 A5 JP2014508142 A5 JP 2014508142A5
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- 102000004965 antibodies Human genes 0.000 claims 29
- 108090001123 antibodies Proteins 0.000 claims 29
- 239000000427 antigen Substances 0.000 claims 29
- 102000038129 antigens Human genes 0.000 claims 29
- 108091007172 antigens Proteins 0.000 claims 29
- 239000008194 pharmaceutical composition Substances 0.000 claims 29
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 claims 9
- 125000000267 glycino group Chemical group [H]N([*])C([H])([H])C(=O)O[H] 0.000 claims 8
- 108010028554 LDL Cholesterol Proteins 0.000 claims 7
- 238000002347 injection Methods 0.000 claims 7
- 239000007924 injection Substances 0.000 claims 7
- 239000000243 solution Substances 0.000 claims 7
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 claims 5
- 239000002552 dosage form Substances 0.000 claims 5
- HVYWMOMLDIMFJA-DPAQBDIFSA-N (3β)-Cholest-5-en-3-ol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 4
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 3
- 125000000510 L-tryptophano group Chemical group [H]C1=C([H])C([H])=C2N([H])C([H])=C(C([H])([H])[C@@]([H])(C(O[H])=O)N([H])[*])C2=C1[H] 0.000 claims 3
- 102100005352 PCSK9 Human genes 0.000 claims 3
- 101700000651 PCSK9 Proteins 0.000 claims 3
- 239000003937 drug carrier Substances 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000000546 pharmaceutic aid Substances 0.000 claims 3
- 102000018616 Apolipoproteins B Human genes 0.000 claims 2
- 108010027006 Apolipoproteins B Proteins 0.000 claims 2
- 229940107161 Cholesterol Drugs 0.000 claims 2
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 2
- COLNVLDHVKWLRT-QMMMGPOBSA-N L-phenylalanine Chemical compound OC(=O)[C@@H](N)CC1=CC=CC=C1 COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 claims 2
- 125000003295 alanine group Chemical group N[C@@H](C)C(=O)* 0.000 claims 2
- 102000005666 Apolipoprotein A-I Human genes 0.000 claims 1
- 108010059886 Apolipoprotein A-I Proteins 0.000 claims 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 1
- 229940071643 Prefilled Syringe Drugs 0.000 claims 1
- 210000002966 Serum Anatomy 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 230000002459 sustained Effects 0.000 claims 1
Claims (24)
- 約40mg〜約500mgのヒトプロタンパク質コンバターゼスブチリシン/ケキシンタイプ9(hPCSK9)と特異的に結合する抗体又はその抗原結合フラグメントを、薬学的に許容可能な賦形剤又は担体と共に含有する、医薬組成物であって、
ここで、抗体又はその抗原結合フラグメントが、3つの重鎖相補性決定領域(HCDR)1〜3及び3つの軽鎖相補性決定領域(LCDR)1〜3を含むか、又は、当該HCDR及びLCDRを含む抗体又はその抗原結合フラグメントとhPCSK9との結合に対して競合し、そしてここで:
HCDR1は、X1−X2−X3−X4−X5−X6−X7−X8のアミノ酸配列(配列番号745)を含み、ここで、X1はGlyであり、X2はPheであり、X3はThrであり、X4はPheであり、X5はSer又はAsnであり、X6はSer又はAsnであり、X7はTyr又はHisであり、及びX8はAla又はTrpであり;
HCDR2は、X1−X2−X3−X4−X5−X6−X7−X8のアミノ酸配列(配列番号746)を含み、ここでX1はIleであり、X2はSer又はAsnであり、X3はGly又はGlnであり、X4はAsp又はSerであり、X5はGlyであり、X6はSer又はGlyであり、X7はThr又はGluであり、及びX8はThr又はLysであり;
HCDR3は、X1−X2−X3−X4−X5−X6−X7−X8−X9−X10−X11−X12−X13−X14−X15−X16−X17−X18−X19−X20のアミノ酸配列(配列番号747)を含み、ここで、X1はAlaであり、X2はArg又はLysであり、X3はAspであり、X4はSer又はIleであり、X5はAsn又はValであり、X6はLeu又はTrpであり、X7はGly又はMetであり、X8はAsn又はValであり、X9はPhe又はTyrであり、X10はAspであり、X11はLeu又はMetであり、X12はAsp又は存在せず、X13はTyr又は存在せず、X14はTyr又は存在せず、X15はTyr又は存在せず、X16はTyr又は存在せず、X17はGly又は存在せず、X18はMet又は存在せず、X19はAsp又は存在せず、及びX20はVal又は存在せずであり;
LCDR1は、X1−X2−X3−X4−X5−X6−X7−X8−X9−X10−X11−X12のアミノ酸配列(配列番号748)を含み、ここで、 X1はGlnであり、X2はSerであり、X3はVal又はLeuであり、X4はLeuであり、X5はHis又はTyrであり、X6はArg又はSerであり、X7はSer又はAsnであり、X8はAsn又はGlyであり、X9はAsnであり、X10はArg又はAsnであり、X11はAsn又はT
yrであり、及びX12はPhe又は存在せずであり;
LCDR2は、X1−X2−X3のアミノ酸配列(配列番号749)を含み、ここで、X1はTrp又はLeuであり、X2はAla又はGlyであり、及びX3はSerであり;並びに、
LCDR3は、X1−X2−X3−X4−X5−X6−X7−X8−X9のアミノ酸配列(配列番号750)を含み、ここで X1はGln又はMetであり、X2はGlnであり、X3はTyr又はThrであり、X4はTyr又はLeuであり、X5はThr又はGlnであり、X6はThrであり、X7はProであり、X8はTyr又はLeuであり、及びX9はThrである、
上記医薬組成物。 - 抗体又はその抗原結合フラグメントが、配列番号76、78及び80の3つのHCDR並びに配列番号84、86及び88の3つのLCDRを含むか、又は、配列番号76、78及び80の3つのHCDR並びに配列番号84、86及び88の3つのLCDRを含む抗体又はその抗原結合フラグメントとhPCSK9との結合に対して競合する、請求項1に記載の医薬組成物。
- 抗体又はその抗原結合フラグメントが、それぞれ配列番号90及び92の重鎖変更可能領域(HCVR)及び軽鎖変更可能領域(LCVR)を含むか、又は、それぞれ配列番号90及び92のHCVR及びLCVRを含む抗体又はその抗原結合フラグメントとhPCSK9との結合に対して競合する、請求項1に記載の医薬組成物。
- 有効量の抗体又はその抗原結合フラグメントを含み、ここで投与量が、投与後、少なくとも14日、少なくとも15日、少なくとも16日、少なくとも17日、少なくとも18日、少なくとも19日、少なくとも20日、少なくとも21日、少なくとも22日、少なくとも23日、又は少なくとも28日間にわたる低密度リポタンパク質コレステロール(LDL−C)レベルの持続的低下のために十分である、請求項1に記載の医薬組成物。
- 請求項1に記載の医薬組成物であって、抗体又はその抗原結合フラグメントが以下の特徴:
a.被験者へ50mgの投与量が隔週投与の投与計画(1週間おき、E2W)で投与されたとき、LDL−Cレベルの、少なくとも14日間にわたる持続的低下と共に、投与前レベルに対して少なくとも−25%〜−40%の低下;
b.被験者へ100mgの投与量がE2Wで投与されたとき、LDL−Cレベルの、少なくとも14日間にわたる持続的低下と共に、投与前レベルに対して少なくとも−50%〜−65%の低下;
c.被験者へ150mgの投与量がE2Wで投与されたとき、LDL−Cレベルの、少なくとも14日間にわたる持続的低下と共に、投与前レベルに対して少なくとも−60%〜−75%の低下;
d.被験者へ200mgの投与量が4週毎投与の投与計画(E4W)で投与されたとき、LDL−Cレベルの、少なくとも28日間にわたる持続的低下と共に、投与前レベルに対して少なくとも−40%〜−75%の低下;
e.被験者へ300mgの投与量がE4Wで投与されたとき、LDL−Cレベルの、少なくとも28日間にわたる持続的低下と共に、投与前レベルに対して少なくとも−50%〜−75%の低下;
f.被験者へ150mgの投与量がE2Wで投与されたとき、血清HDLコレステロールレベルの、投与前レベルに対して少なくとも2%、少なくとも2.5%、少なくとも3%、少なくとも3.5%、少なくとも4%、少なくとも4.5%、少なくとも5%、又は少なくとも5.5%の上昇;
g.被験者へ投与されたときに、トロポニンレベルへの測定可能な影響はほとんどない
又は全くない;
h.被験者へ投与されたときに、総コレステロールレベル、ApoBレベル、非HDL−Cレベル、ApoB/ApoA−1比の1つ又はそれ以上の上昇;
の1つ又はそれ以上を有する、上記医薬組成物。 - 約40mg、約50mg、約75mg、約100mg、約150mg、約200mg、約250mg、約300mg、約350mg、約400mg、約450mg又は約500mgの抗体又はその抗原結合フラグメントを含む、請求項1に記載の医薬組成物。
- 約75mgの抗体又はその抗原結合フラグメントを含む、請求項1に記載の医薬組成物。
- 約150mgの抗体又はその抗原結合フラグメントを含む、請求項1に記載の医薬組成物。
- 約300mgの抗体又はその抗原結合フラグメントを含む、請求項1に記載の医薬組成物。
- 抗体又はその抗原結合フラグメントが液体製剤中に含まれる、請求項1に記載の医薬組成物。
- 液体製剤が、抗体又はその抗原結合フラグメントを1ml容量当り約40mg〜約500mg含む注射溶液である、請求項10に記載の医薬組成物。
- 注射溶液が、抗体又はその抗原結合フラグメントを1ml容量当り約40mg、約50mg、約75mg、約100mg、約150mg、約200mg、約250mg、約300mg、約350mg、約400mg、約450mg又は約500mg含む、請求項11に記載の医薬組成物。
- 注射溶液が、抗体又はその抗原結合フラグメントを1ml容量当り75mg含む、請求項12に記載の医薬組成物。
- 注射溶液が、抗体又はその抗原結合フラグメントを1ml容量当り150mg含む、請求項12に記載の医薬組成物。
- 注射溶液が、抗体又はその抗原結合フラグメントを1ml容量当り300mg含む、請求項12に記載の医薬組成物。
- 抗体又はその抗原結合フラグメントが単位剤形に含まれ、単位剤形が、約40mg、約50mg、約75mg、約100mg、約150mg、約200mg、約250mg、約300mg、約350mg、約400mg、約450mg、又は約500mgの抗体又はその抗原結合フラグメントを含む、請求項1に記載の医薬組成物。
- 単位剤形が、抗体又はその抗原結合フラグメントを75mg含む、請求項16に記載の医薬組成物。
- 単位剤形が、抗体又はその抗原結合フラグメントを150mg含む、請求項16に記載の医薬組成物。
- 単位剤形が、抗体又はその抗原結合フラグメントを300mg含む、請求項16に記載
の医薬組成物。 - 液体製剤が、バイアル、薬袋 プレフィルドシリンジ、プレフィルド自己注射器、再使用シリンジ用カートリッジ、及びアプリケータから成る群から選択される密封容器中に含まれる、請求項10に記載の医薬組成物。
- 請求項1に記載の医薬組成物、及び容器を含む、製品。
- 抗体又はその抗原結合フラグメントが、hPCSK9(配列番号755)の位置238、153、159及び343における1つ又はそれ以上のアミノ酸残基を含むエピトープを結合する、請求項1に記載の医薬組成物。
- ヒトプロタンパク質コンバターゼスブチリシン/ケキシンタイプ9(hPCSK9)と特異的に結合する抗体又はその抗原結合フラグメントの75mgを、薬学的に許容可能な賦形剤又は担体と共に含む医薬組成物であって、ここで、抗体又はその抗原結合フラグメントが、それぞれ配列番号90及び92の重鎖変更可能領域(HCVR)及び軽鎖変更可能領域(LCVR)を含み、そしてここで、医薬組成物が1mlの注射溶液である、上記医薬組成物。
- ヒトプロタンパク質コンバターゼスブチリシン/ケキシンタイプ9(hPCSK9)と特異的に結合する抗体又はその抗原結合フラグメントの150mgを、薬学的に許容可能な賦形剤又は担体と共に含む医薬組成物であって、ここで、抗体又はその抗原結合フラグメントが、それぞれ配列番号90及び92の重鎖変更可能領域(HCVR)及び軽鎖変更可能領域(LCVR)を含み、そしてここで、医薬組成物が1mlの注射溶液である、上記医薬組成物。
Applications Claiming Priority (21)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 | ||
EP11305089A EP2481758A1 (en) | 2011-01-28 | 2011-01-28 | Human antibodies to PSCK9 for use in methods of treating particular groups of subjects (11566) |
EP11305513 | 2011-04-29 | ||
EP11305514 | 2011-04-29 | ||
EP11305513.1 | 2011-04-29 | ||
EP11305514.9 | 2011-04-29 | ||
EP11306040 | 2011-08-12 | ||
EP11306040.4 | 2011-08-12 | ||
EP11306039 | 2011-08-12 | ||
EP11306039.6 | 2011-08-12 | ||
EP11306201.2 | 2011-09-22 | ||
EP11306201 | 2011-09-22 | ||
EP11306202.0 | 2011-09-22 | ||
EP11306202 | 2011-09-22 | ||
EP11306449 | 2011-11-08 | ||
EP11306449.7 | 2011-11-08 | ||
EP11306450 | 2011-11-08 | ||
EP11306450.5 | 2011-11-08 | ||
PCT/EP2012/051321 WO2012101253A1 (en) | 2011-01-28 | 2012-01-27 | Pharmaceutical compositions comprising human antibodies to pcsk9 |
Related Child Applications (1)
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JP2017000850A Division JP2017095491A (ja) | 2011-01-28 | 2017-01-06 | Pcsk9に対するヒト抗体を含んでなる医薬組成物 |
Publications (2)
Publication Number | Publication Date |
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JP2014508142A JP2014508142A (ja) | 2014-04-03 |
JP2014508142A5 true JP2014508142A5 (ja) | 2015-03-19 |
Family
ID=45529125
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JP2013550891A Active JP6375113B2 (ja) | 2011-01-28 | 2012-01-27 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2013550892A Pending JP2014508142A (ja) | 2011-01-28 | 2012-01-27 | Pcsk9に対するヒト抗体を含んでなる医薬組成物 |
JP2017000849A Pending JP2017095490A (ja) | 2011-01-28 | 2017-01-06 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2017000850A Pending JP2017095491A (ja) | 2011-01-28 | 2017-01-06 | Pcsk9に対するヒト抗体を含んでなる医薬組成物 |
JP2018168406A Active JP6730388B2 (ja) | 2011-01-28 | 2018-09-10 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2020114604A Active JP7140800B2 (ja) | 2011-01-28 | 2020-07-02 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2022116860A Pending JP2022141869A (ja) | 2011-01-28 | 2022-07-22 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
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JP2013550891A Active JP6375113B2 (ja) | 2011-01-28 | 2012-01-27 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
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JP2017000849A Pending JP2017095490A (ja) | 2011-01-28 | 2017-01-06 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2017000850A Pending JP2017095491A (ja) | 2011-01-28 | 2017-01-06 | Pcsk9に対するヒト抗体を含んでなる医薬組成物 |
JP2018168406A Active JP6730388B2 (ja) | 2011-01-28 | 2018-09-10 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2020114604A Active JP7140800B2 (ja) | 2011-01-28 | 2020-07-02 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
JP2022116860A Pending JP2022141869A (ja) | 2011-01-28 | 2022-07-22 | 被験者の特定のグループを処置する方法において使用するためのpcsk9に対するヒト抗体 |
Country Status (38)
Country | Link |
---|---|
US (6) | US9682013B2 (ja) |
EP (4) | EP2668211A1 (ja) |
JP (7) | JP6375113B2 (ja) |
KR (6) | KR20200133826A (ja) |
CN (4) | CN103476796A (ja) |
AR (3) | AR084939A1 (ja) |
AU (5) | AU2012210480B2 (ja) |
BR (2) | BR112013018740A2 (ja) |
CA (2) | CA2825778A1 (ja) |
CL (2) | CL2013002162A1 (ja) |
CO (2) | CO6751276A2 (ja) |
CR (1) | CR20130406A (ja) |
CY (1) | CY1121236T1 (ja) |
DK (1) | DK2668212T3 (ja) |
DO (1) | DOP2013000170A (ja) |
EC (1) | ECSP13012792A (ja) |
ES (3) | ES2674600T3 (ja) |
GT (1) | GT201300186A (ja) |
HK (1) | HK1255729A1 (ja) |
HR (1) | HRP20180959T1 (ja) |
HU (1) | HUE039258T2 (ja) |
IL (5) | IL227657B (ja) |
LT (1) | LT2668212T (ja) |
MA (1) | MA34923B1 (ja) |
MX (4) | MX347602B (ja) |
MY (2) | MY176600A (ja) |
NI (1) | NI201300064A (ja) |
PE (2) | PE20181052A1 (ja) |
PH (1) | PH12021500018A1 (ja) |
PL (3) | PL2668212T3 (ja) |
PT (1) | PT2668212T (ja) |
RS (1) | RS57339B1 (ja) |
RU (4) | RU2016142273A (ja) |
SG (2) | SG192118A1 (ja) |
SI (1) | SI2668212T1 (ja) |
TW (3) | TWI625127B (ja) |
WO (3) | WO2012101253A1 (ja) |
ZA (2) | ZA201305524B (ja) |
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