Title:
MEDICINE
Document Type and Number:
WIPO Patent Application WO/2019/004466
Kind Code:
A1
Abstract:
Provided is a medicine for safely treating a patient who needs to be treated with the use of pemafibrate, a salt thereof or a solvate of the same (hereinafter called "pemafibrate treatment"). The medicine for treating a patient who needs the pemafibrate treatment comprises pemafibrate, a salt thereof or a solvate of the same as an active ingredient. The treatment using the aforesaid medicine involves a step for avoiding or stopping the concomitant use of the medicine with another medicine comprising an OATP1B inhibitor to prevent an increase in the plasma pemafibrate concentration at the concomitant use of these medicines, or a step for decreasing the dosage of pemafibrate, a salt thereof or a solvate of the same.
Inventors:
OSHIMA RYU (JP)
ITO MASATOSHI (JP)
NAGAI CHISATO (JP)
ITO MASATOSHI (JP)
NAGAI CHISATO (JP)
Application Number:
PCT/JP2018/024954
Publication Date:
January 03, 2019
Filing Date:
June 29, 2018
Export Citation:
Assignee:
KOWA CO (JP)
International Classes:
A61K31/423; A61K31/4365; A61K31/496; A61K31/7048; A61K38/12; A61K45/08; A61P1/16; A61P3/06; A61P3/10; A61P9/00; A61P9/10; A61P29/00; A61P43/00
Domestic Patent References:
| WO2005023777A1 | 2005-03-17 |
Foreign References:
| JP2014514359A | 2014-06-19 | |||
| JPH0645622B2 | 1994-06-15 |
Other References:
ISHIBASHI, S. ET AL.: "Effects of K-877, a novel selective PPAR a modulator (SPPARM a), in dyslipidaemic patients: A randomized, double blind, active- and placebo-controlled, phase 2 trial", ATHEROSCLEROSIS, vol. 249, 2016, pages 36 - 43, XP029542969
ANONYMOUS: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIALS.GOV.-U.S. NATIONAL LIBRARY OF MEDICINE, 1 February 2016 (2016-02-01), XP009518294, Retrieved from the Internet [retrieved on 20180717]
ANONYMOUS: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02275988, 27 October 2014 (2014-10-27), XP009518264, Retrieved from the Internet [retrieved on 20180717]
KOWA RESEARCH INSTITUTE, INC.: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02276001, 27 October 2014 (2014-10-27), pages 1 - 3, XP009518265, Retrieved from the Internet [retrieved on 20180717]
KOWA RESEARCH INSTITUTE, INC.: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02922465, 21 December 2016 (2016-12-21), pages 1 - 3, XP009518266, Retrieved from the Internet [retrieved on 20180717]
HARASHIMA, HIDEYOSHI: "[Extract]", SHIN YAKUZAI GAKU = [NEW PHARMACOLOGY], 2011, pages 268 - 269, XP009518204
MINISTRY OF HEALTH, LABOR AND WELFARE PHARMACEUTICAL AND FOOD BUREAU REVIEW AND MANAGEMENT SECTION: "Guidelines for Pharmacokinetic Drug Interaction for Drug Development and Proper Information Provision (Final Draft)", GUIDELINES FOR PHARMACOKINETIC DRUG INTERACTION FOR DRUG DEVELOPMENT AND PROPER INFORMATION PROVISION (FINAL DRAFT), 8 July 2014 (2014-07-08), pages 1 - 80, XP009519644
BABA, YUSUKE ET AL.: "Combination Therapy Using Pemafibrate: Drug Interactions", PROGRESS IN MEDICINE, vol. 37, no. 9, September 2017 (2017-09-01), pages 1051 - 1054, XP009518205, ISSN: 0287-3648
"Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau", 8 July 2014, MHLW, article "Drug Interaction Guideline for Drug Development and Proper Information (Final Draft"
"Guidance for Industry Drug Interaction Studies-Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations Draft Guidance", February 2012, U.S. FOOD AND DRUG ADMINISTRATION
"Guideline on the investigation of drug interactions", 21 June 2012, EUROPEAN MEDICINES AGENCY
"Japanese Pharmacopoeia"
See also references of EP 3646865A4
ANONYMOUS: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIALS.GOV.-U.S. NATIONAL LIBRARY OF MEDICINE, 1 February 2016 (2016-02-01), XP009518294, Retrieved from the Internet
ANONYMOUS: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02275988, 27 October 2014 (2014-10-27), XP009518264, Retrieved from the Internet
KOWA RESEARCH INSTITUTE, INC.: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02276001, 27 October 2014 (2014-10-27), pages 1 - 3, XP009518265, Retrieved from the Internet
KOWA RESEARCH INSTITUTE, INC.: "Drug-Drug Interaction Study in Healthy Adult Volunteers", CLINICALTRIAL.GOV, vol. NCT02922465, 21 December 2016 (2016-12-21), pages 1 - 3, XP009518266, Retrieved from the Internet
HARASHIMA, HIDEYOSHI: "[Extract]", SHIN YAKUZAI GAKU = [NEW PHARMACOLOGY], 2011, pages 268 - 269, XP009518204
MINISTRY OF HEALTH, LABOR AND WELFARE PHARMACEUTICAL AND FOOD BUREAU REVIEW AND MANAGEMENT SECTION: "Guidelines for Pharmacokinetic Drug Interaction for Drug Development and Proper Information Provision (Final Draft)", GUIDELINES FOR PHARMACOKINETIC DRUG INTERACTION FOR DRUG DEVELOPMENT AND PROPER INFORMATION PROVISION (FINAL DRAFT), 8 July 2014 (2014-07-08), pages 1 - 80, XP009519644
BABA, YUSUKE ET AL.: "Combination Therapy Using Pemafibrate: Drug Interactions", PROGRESS IN MEDICINE, vol. 37, no. 9, September 2017 (2017-09-01), pages 1051 - 1054, XP009518205, ISSN: 0287-3648
"Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau", 8 July 2014, MHLW, article "Drug Interaction Guideline for Drug Development and Proper Information (Final Draft"
"Guidance for Industry Drug Interaction Studies-Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations Draft Guidance", February 2012, U.S. FOOD AND DRUG ADMINISTRATION
"Guideline on the investigation of drug interactions", 21 June 2012, EUROPEAN MEDICINES AGENCY
"Japanese Pharmacopoeia"
See also references of EP 3646865A4
Attorney, Agent or Firm:
THE PATENT CORPORATE BODY ARUGA PATENT OFFICE (JP)
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