Patent application EP16166046A (EP), filed 2016-04-19
Publication number: EP3235496A1
Title: TREATMENT OF ACUTE RENAL FAILURE
Abstract: Methods and formulations comprising an endothelin receptor antagonist such as ambrisentan are provided for the treatment and prevention of acute renal failure associated with renal vasoconstriction.
IPC codes: A61K  31/    00            A I
A61K  31/   505            A I
A61K   9/    00            A I
A61P  13/    12            A I
A61P   9/    08            A I
Claims: number: 1
text: Ambrisentan for use in the treatment of hepatorenal syndrome.
number: 2
text: Ambrisentan for use in the treatment of delayed graft function.
number: 3
text: Ambrisentan for use in the treatment of renal failure following solid-organ transplantation.
number: 4
text: Ambrisentan for use in the pretreatment of kidneys for kidney transplantation.
number: 5
text: Ambrisentan for use in the preservation of kidneys suitable for transplantation.
number: 6
text: Ambrisentan for use in the treatment of a subject to identify a reduced renal function due to vasoconstriction.
number: 7
text: Ambrisentan for use in the treatment of a subject suffering from a reduced kidney function due to vasoconstriction.
number: 8
text: Ambrisentan for use in the treatment of a subject suffering from a hepatorenal disorder, preferably hepatorenal syndrome, and to identify a reduced renal function due to vasoconstriction.
number: 9
text: Ambrisentan for use in the treatment of a subject awaiting a liver transplant and to identify a reduced renal function due to vasoconstriction.
number: 10
text: Ambrisentan for use in the treatment of a subject awaiting a liver transplant and to identify a reduced renal function due to vasoconstriction, and in the absence of an improvement of renal function in the subject, the subject is eligible for a dual liver-kidney transplant, preferably the kidney will be transplanted in the subject.
number: 11
text: Ambrisentan for use in the treatment of a subject, who has previously received a renal transplant, and to identify a reduced renal function due to vasoconstriction.
number: 12
text: A liquid composition for intravenous administration comprising an endothelin receptor antagonist, a buffer and a solvent.
number: 13
text: The composition claim 12 wherein the endothelin receptor antagonist is ambrisentan.
number: 14
text: The composition according to any one of claims 12 and 13, wherein the pH of the composition is at least 7.
number: 15
text: An ampoule containing the liquid composition according to any one of claims 12 to 13 wherein the endothelin receptor antagonist is present at a concentration of at least 0.001 wt% and at most 5 wt%, based on the total weight of the liquid composition.
number: 16
text: A pre-filled syringe containing the liquid composition according to any one of claims 12 to 13 wherein the endothelin receptor antagonist is present at a concentration of at least 0.001 wt% and at most 1 wt%, based on the total weight of the liquid composition.
number: 17
text: An IV container containing the liquid composition according to any one of claims 12 to 13 wherein the endothelin receptor antagonist is present at a concentration of at least 0.00001 wt% and at most 0.05 wt%, based on the total weight of the liquid composition.
Office action: search_report, dated 2017-10-25
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: - J. ZICHA ET AL: "Chronic endothelin A receptor blockade attenuates contribution of sympathetic nervous system to salt hypertension development in adult but not in young Dahl rats", ACTA PHYSIOLOGICA, vol. 205, no. 1, 31 May 2012 (2012-05-31), GB, pages 124 - 132, XP055335387, ISSN: 1748-1708, DOI: 10.1111/j.1748-1716.2012.02395.x
ref_type: npl
severity: background
ref_id: - H WITZIGMANN ET AL: "Administration of a selective endothelin-a receptor antagonist (BSF 208075) improves hepatic warm ischemia/reperfusion injury in pigs", TRANSPLANTATION PROCEEDINGS, vol. 34, no. 6, 1 September 2002 (2002-09-01), ORLANDO, FL; US, pages 2387 - 2388, XP055335394, ISSN: 0041-1345, DOI: 10.1016/S0041-1345(02)03289-X
ref_type: npl
severity: background
ref_id: WO2014138738A1
ref_type: patent
severity: background
ref_id: US2011319333A1
ref_type: patent
severity: background
ref_id: US2015125546A1
ref_type: patent
severity: background
ref_id: - RAINA AMRESH ET AL: "The pathophysiology of endothelin in complications after solid organ transplantation: a potential novel therapeutic role for endothelin receptor antagonists.", TRANSPLANTATION 15 NOV 2012, vol. 94, no. 9, 15 November 2012 (2012-11-15), pages 885 - 893, XP002766000, ISSN: 1534-6080
ref_type: npl
severity: background
ref_id: - L ZHANG: "Ambrisentan improves the outcome of rats with liver transplantation partially through reducing nephrotoxicity", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, vol. 18, no. 17, 1 January 2014 (2014-01-01), pages 2575 - 2583, XP055335399
ref_type: npl
severity: background
ref_id: US2011319333
ref_type: patent
severity: novelty_destroying
ref_id: WO2014138738
ref_type: patent
severity: novelty_destroying
ref_id: US2015125546
ref_type: patent
severity: background
ref_id: - RAINA AMRESH ET AL, "The pathophysiology of endothelin in complications after solid organ transplantation: a potential novel therapeutic role for endothelin receptor antagonists.", TRANSPLANTATION 15 NOV 2012, (20121115), vol. 94, no. 9, ISSN 1534-6080, pages 885 - 893, XP002766000 [X] 2-7 * the whole document * [I] 8-11
ref_type: npl
severity: novelty_destroying
ref_id: - L ZHANG, "Ambrisentan improves the outcome of rats with liver transplantation partially through reducing nephrotoxicity", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, (20140101), vol. 18, no. 17, pages 2575 - 2583, XP055335399 [X] 2-5,7,8 * the whole document * [I] 9
ref_type: npl
severity: novelty_destroying
Final disposition: pending (2017-10-25)