Title:
THROMBOEMBOLISM PREVENTIVE/THERAPEUTIC AGENT FOR THROMBOEMBOLISM PATIENTS HAVING SEVERE RENAL DYSFUNCTION
Document Type and Number:
WIPO Patent Application WO/2013/089164
Kind Code:
A1
Abstract:
Provided are a thromboembolism preventive and/or therapeutic agent, having a high level of safety and capable of being administered orally, for thromboembolism patients having severe renal dysfunction. A thromboembolism preventive and/or therapeutic agent containing edoxaban and characterized by being used in a manner such that 15mg of edoxaban are administered once daily to patients with atrial fibrillation and having severe renal dysfunction.
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Inventors:
KIMURA TETSUYA (JP)
KUMAKURA TOMOHIKO (JP)
TACHIBANA MASAYA (JP)
MATSUMOTO CHIAKI (JP)
ABE KENJI (JP)
KUMAKURA TOMOHIKO (JP)
TACHIBANA MASAYA (JP)
MATSUMOTO CHIAKI (JP)
ABE KENJI (JP)
Application Number:
PCT/JP2012/082279
Publication Date:
June 20, 2013
Filing Date:
December 13, 2012
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
International Classes:
A61K31/4439; A61P7/02; A61P9/10; A61P13/12
Domestic Patent References:
| WO2010071164A1 | 2010-06-24 | |||
| WO2003000657A1 | 2003-01-03 | |||
| WO2003000680A1 | 2003-01-03 | |||
| WO2010071164A1 | 2010-06-24 |
Other References:
RIDOUT, G. ET AL.: "Effect of renal function on edoxaban pharmacokinetics (PK) and on population PK/PK-PD model.", JOURNAL OF CLINICAL PHARMACOLOGY, vol. 49, no. 9, September 2009 (2009-09-01), pages 1124, XP008173592
"Lixiana (R) Tablets 15mg, Lixiana (R) Tablets 30mg Tenpu Bunsho", July 2011 (2011-07-01), XP008173546, Retrieved from the Internet
"Lixiana Tablets 15mg, Lixiana Tablets 30mg Shinsa Hokokusho", 2011, pages 41 - 43, 66 TO 69, XP055150283, Retrieved from the Internet
THROMB. HAEMOST, vol. 104, no. 3, September 2010 (2010-09-01), pages 633 - 41
AM. HEART J., vol. 160, no. 4, October 2010 (2010-10-01), pages 635 - 41
"LIXIANA (registered trademark) tablets", July 2011
THE BRIEF SUMMARY OF APPLICATION MATERIAL, 2.7.6 SUMMARY OF INDIVIDUAL STUDIES, 25 July 2011 (2011-07-25)
"http://www.info.pmda.go.jp/approvalSrch/PharmacySrchInit ?", LIXIANA (REGISTERED TRADEMARK) TABLETS, THE BRIEF SUMMARY OF APPLICATION MATERIAL, 25 July 2011 (2011-07-25)
"The Brief Summary of Application Material, 2.7.2 Clinical Pharmacological Study, 30-32 Section", 25 July 2011
VALIDITY OF REDUCED DOSE FOR RENAL FUNCTIONAL IMPAIRMENT PATIENT AND FOR COMBINED USE WITH P-GP INHIBITOR, 25 July 2011 (2011-07-25)
INDIVIDUAL WITH RENAL FUNCTIONAL IMPAIRMENT, 9 February 2011 (2011-02-09)
ASSESSMENT REPORT, 25 July 2011 (2011-07-25)
CIRC. J., vol. 75, 2011, pages 1539 - 1547
See also references of EP 2792357A4
"Lixiana (R) Tablets 15mg, Lixiana (R) Tablets 30mg Tenpu Bunsho", July 2011 (2011-07-01), XP008173546, Retrieved from the Internet
"Lixiana Tablets 15mg, Lixiana Tablets 30mg Shinsa Hokokusho", 2011, pages 41 - 43, 66 TO 69, XP055150283, Retrieved from the Internet
THROMB. HAEMOST, vol. 104, no. 3, September 2010 (2010-09-01), pages 633 - 41
AM. HEART J., vol. 160, no. 4, October 2010 (2010-10-01), pages 635 - 41
"LIXIANA (registered trademark) tablets", July 2011
THE BRIEF SUMMARY OF APPLICATION MATERIAL, 2.7.6 SUMMARY OF INDIVIDUAL STUDIES, 25 July 2011 (2011-07-25)
"http://www.info.pmda.go.jp/approvalSrch/PharmacySrchInit ?", LIXIANA (REGISTERED TRADEMARK) TABLETS, THE BRIEF SUMMARY OF APPLICATION MATERIAL, 25 July 2011 (2011-07-25)
"The Brief Summary of Application Material, 2.7.2 Clinical Pharmacological Study, 30-32 Section", 25 July 2011
VALIDITY OF REDUCED DOSE FOR RENAL FUNCTIONAL IMPAIRMENT PATIENT AND FOR COMBINED USE WITH P-GP INHIBITOR, 25 July 2011 (2011-07-25)
INDIVIDUAL WITH RENAL FUNCTIONAL IMPAIRMENT, 9 February 2011 (2011-02-09)
ASSESSMENT REPORT, 25 July 2011 (2011-07-25)
CIRC. J., vol. 75, 2011, pages 1539 - 1547
See also references of EP 2792357A4
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
Kimiki Ishibashi (JP)
Kimiki Ishibashi (JP)
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Claims: