Title:
METHOD FOR PREVENTING OR TREATING OSTEOPOROSIS CHARACTERIZED BY ADMINISTERING TERIPARATIDE OR SALT THEREOF TWICE A WEEK
Document Type and Number:
WIPO Patent Application WO/2020/090174
Kind Code:
A1
Abstract:
[Problem] To provide a method for treating and/or preventing osteoporosis with teriparatide or salt thereof and having excellent safety and/or efficacy. [Solution] Provided is a method for treating and/or preventing osteoporosis by employing teriparatide or salt thereof as an active ingredient, wherein teriparatide or salt thereof is administered twice a week in a unit dose of 28.2 μg.
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Inventors:
MINAMIDA TAKESHI (JP)
KATO RYO (JP)
KOIKE AKIRA (JP)
OSE ATSUSHI (JP)
KITAMI AKIHIRO (JP)
MAKIYAMA TAKASHI (JP)
YAMAMOTO HIKARU (JP)
KITAGAWA KAZUHIKO (JP)
TAKAO RYOKO (JP)
KATO RYO (JP)
KOIKE AKIRA (JP)
OSE ATSUSHI (JP)
KITAMI AKIHIRO (JP)
MAKIYAMA TAKASHI (JP)
YAMAMOTO HIKARU (JP)
KITAGAWA KAZUHIKO (JP)
TAKAO RYOKO (JP)
Application Number:
PCT/JP2019/030099
Publication Date:
May 07, 2020
Filing Date:
July 31, 2019
Export Citation:
Assignee:
ASAHI KASEI PHARMA CORP (JP)
International Classes:
A61K38/29; A61P19/10
Domestic Patent References:
| WO2011030774A1 | 2011-03-17 | |||
| WO2000010596A1 | 2000-03-02 |
Foreign References:
| JPH0873376A | 1996-03-19 |
Other References:
FUJITA, T. ET AL.: "Effect of an intermittent weekly dose of human parathyroid hormone (1-34) on osteoporosis: a randomized double-masked prospective study using three dose levels", OSTEOPOROSIS INTERNATIONAL, vol. 9, no. 4, 1999, pages 296 - 306, XP055050510, ISSN: 0937-941X, DOI: 10.1007/s001980050151
HAGINO HIROSHI: "Uses of Novel Drug Treatment for Osteoporosis ''Weekly-Administered Teriparatide Preparation'' (Teribone Hypodermic Injection 56.5 g) for the Elderly", PROGRESS IN MEDICINE, vol. 32, no. 2, 30 November 2011 (2011-11-30), pages 373 - 378, XP009525939, ISSN: 0287-3648
RYUICHI KATO , TETSUYA KAMATAKI: "Toxicity and Safety of Drugs", CHEMICAL EDUCATION, vol. 31, no. 2, 20 April 1983 (1983-04-20), pages 97 - 101, XP055779701, ISSN: 0386-2151, DOI: 10.20665/kagakukyouiku.31.2_97
TAKAKURA AYA : "Higher Frequencies of Teriparatide develops Cortical Porosity", JOURNAL OF JAPANESE SOCIETY OF BONE MORPHOMETRY, vol. 28, no. 1, 20 March 2018 (2018-03-20), pages 31 - 37, XP009525938, ISSN: 0917-4648
TAKAKURA, AYA ET AL.: "Administration frequency as well as dosage of PTH are associated with development of cortical porosity in ovariectomized rats", BONE RESEARCH, vol. 5, no. 17002, 2017, XP055703806, ISSN: 2095-4700
TANAKA SHINYA : "Q&A to Aid Clinical Practice: Teach Us about Drug Treatments for Osteoporosis that are Under Development", GERIATRIC MEDICINE, vol. 56, no. 12, 2018130, pages 1225 - 1230, XP009525937, ISSN: 0387-1088
KUMAGAI, Y. ET AL.: "Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study", CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 28 March 2019 (2019-03-28), XP055703803, ISSN: 2160-7648
JAMA, vol. 285, no. 6, 2001, pages 785 - 795
OSTEOPOROS INT, vol. 9, 1999, pages 296 - 306
J BONE MINER METAB, vol. 22, 2004, pages 104 - 110
PACKAGE INSERT OFTERIBONE(REGISTERED TRADEMARK) SUBCUTANEOUS INJECTION, August 2018 (2018-08-01)
J CLIN ENDOCRINOL METAB, vol. 97, no. 9, 2012, pages 3097 - 3106
ADV THER, vol. 34, 2017, pages 1727 - 1740
N ENGL J MED, vol. 344, no. 19, 2001, pages 1434 - 1441
PACKAGE INSERT OF FORTEO(REGISTERED TRADEMARK) SUBCUTANEOUS INJECTION KIT 600 PG, January 2018 (2018-01-01)
KOTSUSOSHOSHOU NO YOBO TO CHIRYO GAIDORAIN (GUIDELINES FOR OSTEOPOROSIS PREVENTION AND TREATMENT, 2015
GENPATSUSEI KOTSUSOSHOSHOU NO SHINDAN KIJUN (DIAGNOSTIC CRITERIA FOR PRIMARY OSTEOPOROSIS), 2012
JBONE MINER RES, vol. 8, 1993, pages 1137 - 1148
OSTEOPOROS INT, vol. 5, 1995, pages 354 - 370
JOURNAL OF JAPANESE SOCIETY FOR BONE MORPHOMETRY, vol. 28, 2018, pages 31 - 37
"Kotsusoshoshouyou Yaku no Rinsho Hyokahoho ni Kansuru Gaidorain no Kaitei nitsuite (Revision on Guidelines on Clinical Assessment Method for Drugsfor Osteoporosis)", YAKU-SEI-YAKU-SHIN-HATSU (PHARMACEUTICAL SANITATION BUREAU DRUG EXAMINATION MANAGEMENT NOTIFICATION) 0707, no. 1, 2017
BONE, vol. 45, 2009, pages 1053 - 1058
J BONE MINER METAB, vol. 26, 2008, pages 624 - 634
KAGOSHIMA-SHI IHO: "Yakuzai Netsu nitsuite (Drug Fever", JOURNAL OF THE KAGOSHIMA CITY MEDICAL ASSOCIATION, vol. 45, no. 9, 2006
JAPI, vol. 56, 2008, pages 418 - 424
CALCIF TISSUE INT, vol. 94, 2014, pages 170 - 175
ENDOCRINE REVIEWS, vol. 10, no. 4, 1989, pages 420 - 436
ARCH OSTEOPOROS, vol. 13, no. 1, 2018, pages 54
"Pharmaceutical Interview Form Japan Standard Goods Classification Number", IYAKUHIN INTABYU FOHM NIHON HYOJUN SHOHIN BUNRUI BANGO, no. 872439
THE JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE, vol. 101, no. 4, 2012, pages 1007 - 1014
BONEKEY REP, vol. 3, no. 512, 2014
KAWASAKI MEDICAL JOURNAL, vol. 36, no. 2, 2010, pages 153 - 157
"Acute development of cortical porosity and endosteal naive bone formation from the daily but not weekly short-term administration of PTH in rabbit", PLOS ONE, vol. 12, no. 4, pages e0175329
"Iyakuhin no Fukusayo no Jutokudo Bunrui Kijun nitsuite", CLASSIFICATION CRITERIA FOR DEGREE OF SERIOUSNESS OF SIDE EFFECTS OF PHARMACEUTICALS, no. 80, 29 June 1992 (1992-06-29)
HAGINO HIROSHI: "Uses of Novel Drug Treatment for Osteoporosis ''Weekly-Administered Teriparatide Preparation'' (Teribone Hypodermic Injection 56.5 g) for the Elderly", PROGRESS IN MEDICINE, vol. 32, no. 2, 30 November 2011 (2011-11-30), pages 373 - 378, XP009525939, ISSN: 0287-3648
RYUICHI KATO , TETSUYA KAMATAKI: "Toxicity and Safety of Drugs", CHEMICAL EDUCATION, vol. 31, no. 2, 20 April 1983 (1983-04-20), pages 97 - 101, XP055779701, ISSN: 0386-2151, DOI: 10.20665/kagakukyouiku.31.2_97
TAKAKURA AYA : "Higher Frequencies of Teriparatide develops Cortical Porosity", JOURNAL OF JAPANESE SOCIETY OF BONE MORPHOMETRY, vol. 28, no. 1, 20 March 2018 (2018-03-20), pages 31 - 37, XP009525938, ISSN: 0917-4648
TAKAKURA, AYA ET AL.: "Administration frequency as well as dosage of PTH are associated with development of cortical porosity in ovariectomized rats", BONE RESEARCH, vol. 5, no. 17002, 2017, XP055703806, ISSN: 2095-4700
TANAKA SHINYA : "Q&A to Aid Clinical Practice: Teach Us about Drug Treatments for Osteoporosis that are Under Development", GERIATRIC MEDICINE, vol. 56, no. 12, 2018130, pages 1225 - 1230, XP009525937, ISSN: 0387-1088
KUMAGAI, Y. ET AL.: "Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study", CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 28 March 2019 (2019-03-28), XP055703803, ISSN: 2160-7648
JAMA, vol. 285, no. 6, 2001, pages 785 - 795
OSTEOPOROS INT, vol. 9, 1999, pages 296 - 306
J BONE MINER METAB, vol. 22, 2004, pages 104 - 110
PACKAGE INSERT OFTERIBONE(REGISTERED TRADEMARK) SUBCUTANEOUS INJECTION, August 2018 (2018-08-01)
J CLIN ENDOCRINOL METAB, vol. 97, no. 9, 2012, pages 3097 - 3106
ADV THER, vol. 34, 2017, pages 1727 - 1740
N ENGL J MED, vol. 344, no. 19, 2001, pages 1434 - 1441
PACKAGE INSERT OF FORTEO(REGISTERED TRADEMARK) SUBCUTANEOUS INJECTION KIT 600 PG, January 2018 (2018-01-01)
KOTSUSOSHOSHOU NO YOBO TO CHIRYO GAIDORAIN (GUIDELINES FOR OSTEOPOROSIS PREVENTION AND TREATMENT, 2015
GENPATSUSEI KOTSUSOSHOSHOU NO SHINDAN KIJUN (DIAGNOSTIC CRITERIA FOR PRIMARY OSTEOPOROSIS), 2012
JBONE MINER RES, vol. 8, 1993, pages 1137 - 1148
OSTEOPOROS INT, vol. 5, 1995, pages 354 - 370
JOURNAL OF JAPANESE SOCIETY FOR BONE MORPHOMETRY, vol. 28, 2018, pages 31 - 37
"Kotsusoshoshouyou Yaku no Rinsho Hyokahoho ni Kansuru Gaidorain no Kaitei nitsuite (Revision on Guidelines on Clinical Assessment Method for Drugsfor Osteoporosis)", YAKU-SEI-YAKU-SHIN-HATSU (PHARMACEUTICAL SANITATION BUREAU DRUG EXAMINATION MANAGEMENT NOTIFICATION) 0707, no. 1, 2017
BONE, vol. 45, 2009, pages 1053 - 1058
J BONE MINER METAB, vol. 26, 2008, pages 624 - 634
KAGOSHIMA-SHI IHO: "Yakuzai Netsu nitsuite (Drug Fever", JOURNAL OF THE KAGOSHIMA CITY MEDICAL ASSOCIATION, vol. 45, no. 9, 2006
JAPI, vol. 56, 2008, pages 418 - 424
CALCIF TISSUE INT, vol. 94, 2014, pages 170 - 175
ENDOCRINE REVIEWS, vol. 10, no. 4, 1989, pages 420 - 436
ARCH OSTEOPOROS, vol. 13, no. 1, 2018, pages 54
"Pharmaceutical Interview Form Japan Standard Goods Classification Number", IYAKUHIN INTABYU FOHM NIHON HYOJUN SHOHIN BUNRUI BANGO, no. 872439
THE JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE, vol. 101, no. 4, 2012, pages 1007 - 1014
BONEKEY REP, vol. 3, no. 512, 2014
KAWASAKI MEDICAL JOURNAL, vol. 36, no. 2, 2010, pages 153 - 157
"Acute development of cortical porosity and endosteal naive bone formation from the daily but not weekly short-term administration of PTH in rabbit", PLOS ONE, vol. 12, no. 4, pages e0175329
"Iyakuhin no Fukusayo no Jutokudo Bunrui Kijun nitsuite", CLASSIFICATION CRITERIA FOR DEGREE OF SERIOUSNESS OF SIDE EFFECTS OF PHARMACEUTICALS, no. 80, 29 June 1992 (1992-06-29)
Attorney, Agent or Firm:
HOSODA, Yoshinori (JP)
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