JPWO2019157047A5 - - Google Patents
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- Publication number
- JPWO2019157047A5 JPWO2019157047A5 JP2020542621A JP2020542621A JPWO2019157047A5 JP WO2019157047 A5 JPWO2019157047 A5 JP WO2019157047A5 JP 2020542621 A JP2020542621 A JP 2020542621A JP 2020542621 A JP2020542621 A JP 2020542621A JP WO2019157047 A5 JPWO2019157047 A5 JP WO2019157047A5
- Authority
- JP
- Japan
- Prior art keywords
- migalastat
- salt
- use according
- patient
- pregnancy
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- LXBIFEVIBLOUGU-DPYQTVNSSA-N (2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol Chemical compound OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O LXBIFEVIBLOUGU-DPYQTVNSSA-N 0.000 claims 18
- 229950007469 migalastat Drugs 0.000 claims 18
- 150000003839 salts Chemical class 0.000 claims 18
- 239000011780 sodium chloride Substances 0.000 claims 18
- 230000035935 pregnancy Effects 0.000 claims 10
- 230000001605 fetal Effects 0.000 claims 2
- 239000012458 free base Substances 0.000 claims 2
- 230000000977 initiatory Effects 0.000 claims 2
- ZJIHMALTJRDNQI-OLALXQGDSA-N (2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol;hydrochloride Chemical group Cl.OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O ZJIHMALTJRDNQI-OLALXQGDSA-N 0.000 claims 1
- 208000001590 Congenital Abnormality Diseases 0.000 claims 1
- 206010010356 Congenital anomaly Diseases 0.000 claims 1
- 201000005603 Fabry disease Diseases 0.000 claims 1
- 230000035606 childbirth Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229950010505 migalastat hydrochloride Drugs 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
Claims (15)
- 約１００ｍｇ～約１５０ｍｇ遊離塩基当量（ＦＢＥ）の治療有効用量のミガラスタット又はその塩を含む製剤を１日おきに１回の頻度で患者に投与することによる、出産能のある女性患者におけるファブリー病の治療における使用のためのミガラスタット又はその塩であって、前記患者は、治療時に有効な受胎調節を行うように前記治療の開始前に指示されない、使用のためのミガラスタット又はその塩。
- 前記患者が前記治療時に有効な受胎調節を利用しない、請求項１に記載の使用のためのミガラスタット又はその塩。
- 前記患者が前記治療の開始後に妊娠する、請求項１又は２に記載の使用のためのミガラスタット又はその塩。
- 前記治療が前記患者の妊娠の同定時に中断される、請求項３に記載の使用のためのミガラスタット又はその塩。
- 前記患者の妊娠が少なくとも３７週の胎齢を有する子の出生をもたらす、請求項３又は４に記載の使用のためのミガラスタット又はその塩。
- 前記患者の妊娠が子の胎齢に基づいて正常体重の子の出生をもたらす、請求項３～５のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記患者の妊娠が出生時欠損を伴うことなく子をもたらす、請求項３～６のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記治療有効用量が約１２３ｍｇ遊離塩基当量（ＦＢＥ）のミガラスタット又はその塩である、請求項１～７のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記ミガラスタットの塩がミガラスタット塩酸塩である、請求項１～８のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠中に少なくとも２週間にわたり投与される、請求項３～９のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠中に少なくとも６週間にわたり投与される、請求項３～１０のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠中に少なくとも１２週間にわたり投与される、請求項３～１１のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠の第１三半期に投与される、請求項３～１２のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠の第２三半期に投与される、請求項３～１３のいずれか一項に記載の使用のためのミガラスタット又はその塩。
- 前記製剤が前記患者の妊娠の最初の１６週間で投与される、請求項３～１４のいずれか一項に記載の使用のためのミガラスタット又はその塩。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862626955P | 2018-02-06 | 2018-02-06 | |
| US62/626,955 | 2018-02-06 | ||
| PCT/US2019/016841 WO2019157047A1 (en) | 2018-02-06 | 2019-02-06 | Use of migalastat for treating fabry disease in pregnant patients |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2021512906A JP2021512906A (ja) | 2021-05-20 |
| JPWO2019157047A5 true JPWO2019157047A5 (ja) | 2022-02-15 |
Family
ID=65494618
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020542621A Pending JP2021512906A (ja) | 2018-02-06 | 2019-02-06 | 妊娠患者におけるファブリー病の治療のためのミガラスタットの使用 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US11357784B2 (ja) |
| EP (1) | EP3749307A1 (ja) |
| JP (1) | JP2021512906A (ja) |
| KR (1) | KR20200128676A (ja) |
| CN (1) | CN111971044A (ja) |
| AU (1) | AU2019217868A1 (ja) |
| CA (1) | CA3090496C (ja) |
| WO (1) | WO2019157047A1 (ja) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK2533050T6 (da) | 2006-05-16 | 2015-09-21 | Amicus Therapeutics Inc | Behandlingsmuligheder ved Fabrys sygdom |
| HUE051377T2 (hu) | 2008-02-12 | 2021-03-01 | Amicus Therapeutics Inc | Eljárás betegségek gyógyászati chaperonnal történõ kezelésére adott válasz elõrejelzésére |
| KR102631805B1 (ko) | 2017-05-30 | 2024-01-31 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 신장 손상을 갖는 파브리 환자를 치료하는 방법 |
| KR20200128676A (ko) | 2018-02-06 | 2020-11-16 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 임신 환자의 파브리병 치료를 위한 미갈라스타트의 용도 |
| US11833164B2 (en) | 2019-08-07 | 2023-12-05 | Amicus Therapeutics, Inc. | Methods of treating Fabry disease in patients having a mutation in the GLA gene |
| US11623916B2 (en) | 2020-12-16 | 2023-04-11 | Amicus Therapeutics, Inc. | Highly purified batches of pharmaceutical grade migalastat and methods of producing the same |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6274597B1 (en) | 1998-06-01 | 2001-08-14 | Mount Sinai School Of Medicine Of New York University | Method of enhancing lysosomal α-Galactosidase A |
| KR20130119506A (ko) * | 2004-09-24 | 2013-10-31 | 베스 이스라엘 데코니스 메디칼 센터 | 임신성 합병증의 진단 및 치료 방법 |
| ES2537089T3 (es) | 2005-06-08 | 2015-06-02 | Amicus Therapeutics, Inc. | Purificación de imino- y amino-azúcares |
| DK2533050T6 (da) | 2006-05-16 | 2015-09-21 | Amicus Therapeutics Inc | Behandlingsmuligheder ved Fabrys sygdom |
| CA2682441A1 (en) | 2007-03-30 | 2008-10-09 | Amicus Therapeutics, Inc. | Method for the treatment of fabry disease using pharmacological chaperones |
| US9999618B2 (en) * | 2007-04-26 | 2018-06-19 | Amicus Therapeutics, Inc. | Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones |
| EP2150254A4 (en) | 2007-04-26 | 2010-11-10 | Amicus Therapeutics Inc | DOSAGES FOR THE TREATMENT OF LYSOSOMAL STORAGE DISEASES WITH PHARMACOLOGICAL CHAPTERONES |
| HUE051377T2 (hu) | 2008-02-12 | 2021-03-01 | Amicus Therapeutics Inc | Eljárás betegségek gyógyászati chaperonnal történõ kezelésére adott válasz elõrejelzésére |
| US8321148B2 (en) | 2008-10-24 | 2012-11-27 | Amicus Therapeutics, Inc. | Multiple compartment dosing model |
| US9206457B2 (en) | 2009-05-26 | 2015-12-08 | Amicus Therapeutics, Inc. | Utilization of pharmacological chaperones to improve manufacturing and purification of biologics |
| ES2768995T3 (es) | 2009-11-17 | 2020-06-24 | Baylor Res Institute | 1-desoxigalactonojirimicina para el uso en el tratamiento de una enfermedad cardíaca |
| SG193379A1 (en) * | 2011-03-11 | 2013-10-30 | Amicus Therapeutics Inc | Dosing regimens for the treatment of fabry disease |
| US10155027B2 (en) | 2012-07-17 | 2018-12-18 | Amicus Therapeutics, Inc. | Alpha-galactosidase A and 1-deoxygalactonojirimycin co-formulation for the treatment of fabry disease |
| US9694056B2 (en) | 2012-07-17 | 2017-07-04 | Amicus Therapeutics, Inc. | α-galactosidase A and 1-deoxygalactonojirimycin co-formulation |
| EP3432882B1 (en) | 2016-03-22 | 2021-09-01 | Amicus Therapeutics, Inc. | Methods of treating fabry disease in patients having the g9331a mutation in the gla gene |
| US20190183869A1 (en) | 2016-07-19 | 2019-06-20 | Amicus Therapeutics, Inc. | Treatment of fabry disease in ert-naïve and ert-experienced patients |
| TW201829770A (zh) | 2017-01-10 | 2018-08-16 | 美商阿米庫斯醫療股份有限公司 | 用於治療fabry氏病之重組α-半乳糖苷酶A |
| KR102631805B1 (ko) | 2017-05-30 | 2024-01-31 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 신장 손상을 갖는 파브리 환자를 치료하는 방법 |
| KR20200044908A (ko) | 2017-08-28 | 2020-04-29 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 파브리병을 앓는 환자에서 심장 기능을 강화 및/또는 안정화시키는 방법 |
| PL3749308T3 (pl) | 2018-02-06 | 2024-03-25 | Amicus Therapeutics, Inc. | Leczenie pacjentów z klasyczną chorobą fabry’ego migalastatem |
| KR20200128676A (ko) | 2018-02-06 | 2020-11-16 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 임신 환자의 파브리병 치료를 위한 미갈라스타트의 용도 |
| US20210315875A1 (en) | 2018-08-20 | 2021-10-14 | Amicus Therapeutics, Inc. | Methods of Treating Fabry Disease in Patients Having a Mutation in the GLA Gene |
| CA3141226A1 (en) | 2019-06-11 | 2020-12-17 | Franklin Johnson | Methods of treating fabry disease in patients having renal impairment |
| US11833164B2 (en) | 2019-08-07 | 2023-12-05 | Amicus Therapeutics, Inc. | Methods of treating Fabry disease in patients having a mutation in the GLA gene |
| AU2021218578A1 (en) | 2020-02-10 | 2022-08-25 | Amicus Therapeutics, Inc. | Methods of treating Fabry disease |
-
2019
- 2019-02-06 KR KR1020207025691A patent/KR20200128676A/ko unknown
- 2019-02-06 US US16/967,827 patent/US11357784B2/en active Active
- 2019-02-06 AU AU2019217868A patent/AU2019217868A1/en active Pending
- 2019-02-06 WO PCT/US2019/016841 patent/WO2019157047A1/en unknown
- 2019-02-06 EP EP19706178.1A patent/EP3749307A1/en active Pending
- 2019-02-06 CA CA3090496A patent/CA3090496C/en active Active
- 2019-02-06 CN CN201980024425.7A patent/CN111971044A/zh active Pending
- 2019-02-06 JP JP2020542621A patent/JP2021512906A/ja active Pending
-
2022
- 2022-06-13 US US17/838,820 patent/US20220387462A1/en active Pending
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