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ADVICE SUMMARY APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT Product name: VETMEDIN 0.75 MG/ML INJECTABLE SOLUTION FOR DOGS Applicant: BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION Product number: 67201 Application number: 55445 Purpose of Application and Description of Use: Registration of a pimobendan 0.75 mg/mL injectable solution product for the initiation of treatment of congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) in dogs. Active Constituent(s): PIMOBENDAN Regulatory Decision: To grant the application subject to the following conditions: Standard Conditions of Registration/Approval 1. 2. 3. 4. Containers must meet AgVet Code Regulation 18 Product must not be supplied without meeting GMP Requirements Label must contain an Expiry Date and Batch Number Product Label (MPL) must comply with Labelling Standard / Code For full conditions, refer to Standard Conditions for Applications on the APVMA website. 55445 Page 1 of 7 KP25S_F39 Version: 2 Issued: 14/08/2007 ADVICE External Efficacy Reviewer An external reviewer has evaluated data submitted by the applicant to support the efficacy and target animal safety of the proposed product Vetmedin 0.75 mg/mL Injectable Solution For Dogs (67201), containing the active constituent pimobendan. The proposed product is to be used for the initiation of treatment of congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) in dogs. The submitted data included published literature supporting the safety, efficacy and pharmacology of the active constituent, target animal safety studies, bioequivalence/pharmacology studies, pharmacovigilance data and a confirmatory field efficacy and safety study. Based on the advice of the external reviewer and the relied on data, the APVMA determines that the use of the product in accordance with the label instructions would not be likely to have an adverse effect on the safety of target animals and that use of the product in accordance with the recommendations for its use that the APVMA approves would be effective. Data relied on to provide the advice Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party 65103 S Prof Adrian Boswood Detailed and Critical Summary - Vetmedin 0.75 mg/mL solution for injection for dogs. Efficacy Documentation. Expert Report 4 March 2011 Efficacy and Safety Efficacy Applicant 65108 S U Langbein Vetmedin 1.25mg, 2.5 mg and 5 mg chewable tablets for dogs. Periodic safety update report. August 1 2008 until January 31 2009 2009 Efficacy and Safety Efficacy Applicant 65104 S Professor Herve Pouliquen Detailed Critical Summary - Vetmedin 0.75 mg/mL solution for injection for dogs - Safety Documentation Expert Report 9 March 2011 Efficacy and Safety Efficacy Applicant 65092 S M Markert Comparison of the effect of single, therapeutic doses of Vetmedin chewable tablets and Vetmedin injectable on hemodynamic and electrocardiogrphic parameters in conscious dogs 2008 Efficacy and Safety Efficacy Applicant 55445 Page 2 of 7 Inherited Application No. KP25S_F39 Version: 2 Issued: 14/08/2007 Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party 65087 S M Market Comparison of the effect of single therapeutic doses of Vetmedin capsules and Vetmedin chewable tablets on hemodynamic and electrocardiographic parameters in conscious dogs 2006 Efficacy and Safety Efficacy Applicant 65098 S CW Lombard, O Jons, CM Bussadori Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs 2006 Efficacy and Safety Other Information Public 65112 S BN Bonnett, A Egenvall, A Hedhammar et al Mortality in over 350,000 insured Swedish dogs 19952000: I Breed-, gender-, age- and cause-specific rates 2005 Efficacy and Safety Other Information Public 65113 S JW Buchanan Prevalence of Cardiovascular Disorders 1999 Efficacy and Safety Other Information Public 65114 S MA Oyama Neurohormal activation in canine degenerative mitral valve disease: implications on pathophysiology and treatment 2009 Efficacy and Safety Other Information Public 65115 S RLStepien, A Boswood Cardiovascular emergencies. In: King LG, Boag A, eds, 2007 Efficacy and Safety Other Information Public 65110 S U Langbein Vetmedin 1.25 mg, 2.5 mg and 5 mg capsules for dogs. Periodic safety update report. February 1 2008 until July 31 2008 2009 Efficacy and Safety Other Information Applicant 65117 S JE Tisdale, R Patel, CR Webb et al Electrophysiologic and proarrhythmic effects of intravenous inotropic agents 1995 Efficacy and Safety Other Information Public 65119 S V Luis Fuentes Use of pimobendan in the management of heart failure 2004 Efficacy and Safety Other Information Public 65097 S J Haggstrom, A Boswood, M O'Grady et al Effect of pimobendan or benazepril hydrochloride on survival times in dogs with congestive heart failure caused by naturally occurring myxomatous mitral valve disease: the QUEST study 2008 Efficacy and Safety Other Information Public 55445 Page 3 of 7 Inherited Application No. KP25S_F39 Version: 2 Issued: 14/08/2007 Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party 65121 S C Atkins, J Bonagura, S Ettinger et al Guidelines for the Diagnosis and Treatment of Canine Chronic Valvular Heart Disease 2009 Efficacy and Safety Other Information Public 65122 S MR O'Grady, SL Minors, ML O'Sullivan et al Effect of pimobendan on case fatality rate in doberman pinschers with congestive heart failure caused by dilated cardiomyopathy 2008 Efficacy and Safety Other Information Public 65109 S Boehringer Ingelheim Periodic Safety Update Report Vetmedin 1.25 mg, 2.5 mg and 5 mg capsules. Time Period October 1 2007 until January 31 2008 March 2008 Efficacy and Safety Other Information Applicant 65107 S U Langbein Vetmedin 1.25mg, 2.5 mg and 5 mg chewable tablets for dogs. Periodic safety update report. December 1 2007 until July 31 2008 2008 Efficacy and Safety Other Information Applicant 65094 S BI Periodic Safety Update Report for Vetmedin 1.25 mg, 2.5 mg and 5 mg chewable tablets for dogs 2009 Efficacy and Safety Other Information Applicant 65093 S JN Matthews, DG Altman, MJ Campbell et al Analysis of serial measurements in medical research 1990 Efficacy and Safety Other Information Public 65106 S A Hirsch Vetmedin 1.25mg, 2.5mg and 5 mg chewable tablets for dogs. Periodic Safety update report; June 1 2006 until Novmber 30 2007 2008 Efficacy and Safety Other Information Applicant 65091 S H Pouleur, C Hanet, E Schroder et al Effects of pimobendan (UD-CG 115BS) on left ventricular inotropic state in conscious dogs and in patients with heart failure 1989 Efficacy and Safety Other Information Public 71534 S Markert et al The value added by measuring myocardial contractility in vivo in safety pharmocological profiling of drug candidates 2007 Efficacy and Safety Other Information Public 71535 S Meyners and Markert Correcting the QT Interval for Changes in HR in PreClinical Drug Development 2004 Efficacy and Safety Other Information Public 55445 Page 4 of 7 Inherited Application No. KP25S_F39 Version: 2 Issued: 14/08/2007 Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party 65105 S HG Vogel, Franz jakob Hock, Jochen Maas, Dieter Mayer Drug Discovery and Evaluation: safety and pharmacokinetic assays 2006 Efficacy and Safety Other Information Public 65102 S HS Bender Veterinary Laboratory Medicine, Clinical Pathology, fourth edition. Chapter: muscle 2003 Efficacy and Safety Other Information Public 65100 S A Klumpp, T Trautmann, M Markert et al Optimizing the experimental environment for dog telemetry studies 2006 Efficacy and Safety Other Information Public 65116 S MR Vasko, DB Cartwright, JP Knochel et al Furosemide absorption altered in decompensated congestive heart failure 1985 Efficacy and Safety Other Information Public 75723 S N.Mohren Addendum to the detailed and critical summary on the efficacy documentation (Document No vr 00075471) 21 May 2013 Efficacy and Safety Other Information Applicant 65099 S V Luis Fuentes, B Corcoran, A French et al A double-blind, randomised, placebo-controlled study of pimobendan in dogs with dilated cardiomyopathy 2002 Efficacy and Safety Other Information Public 65086 S J Dammgen Addendum to Clinical Expert Report 2008 Efficacy and Safety Other Information Applicant 65085 S J Dammgen Addendum to Clinical Expert Report 2004 Efficacy and Safety Other Information Applicant 65111 S U Langbein Vetmedin 1.25 mg, 2.5 mg and 5 mg capsules for dogs. Periodic safety report. August 1 2008 until Novmber 30 2008 2009 Efficacy and Safety Other Information Applicant 65084 S G Le Bobbinec, W Diederen Clinical expert report on Vetmedin Capsules (2.5 and 5 mg) (Pimobendan) 1996 Efficacy and Safety Other Information Applicant 55445 Page 5 of 7 Inherited Application No. KP25S_F39 Version: 2 Issued: 14/08/2007 Data No Data Source* Author(s) Title Date Data Type Data Sub-type Authorising Party 65120 S W Diederen, W roth, H Lehmann et al Vetmedin (pimobendan) capsules and chewable tablets for dogs 2008 Efficacy and Safety Pharmacological Data/Studies Applicant 65088 S W Roth, W Diederen Plasma level profile, positive inotropic activity and tissue distribution after intravenous administration of UD-CG 115 BS and UD-CG 212 in dogs 1987 Efficacy and Safety Pharmacological Data/Studies Applicant 65096 S L Lutzen, A Eckenfield, M Bauer et al Subacute toxicity study on the substance UD-CG115 BS with intravenous administration of dogs for 4 weeks 1986 Efficacy and Safety Pharmacological Data/Studies Applicant 65095 S R Serbedija, A Eckenfels, M Bauer et al Subacute toxicity study with substance UD-CG 115 BS in dogs after intravenous administration for 4 weeks 1985 Efficacy and Safety Pharmacological Data/Studies Applicant 65090 S A Greischel Pharmacokinetics of UDCG 115 BS after oral and intravenous administration of 0.5 mg/kg of (14C)-UDCG 115 BS in dogs 1989 Efficacy and Safety Pharmacological Data/Studies Applicant 65089 S W Roth Supporting the rationale to apply pharmacodynamic endpoints instead of pharmacokinetic analysis for assessing the bioequivalence of the Vetmedin chewable tablet versus the marketed Vetmedin capsule information 2006 Efficacy and Safety Pharmacological Data/Studies Applicant 65101 S P Clausing, S Mueller Subcutaneous and intravenous local tolerance study in the beagle dog 2007 Efficacy and Safety Target Animal Safety Studies Applicant 75724 S BI Periodic Safety Update Report. Vetmedin solution for injection 21 May 2013 Efficacy and Safety Target Animal Safety Studies Applicant 75725 S N.Mohren Vetmedin 0.75mg/ml solution for injection for initiation of treatment for congestive heart failure in dogs with acquired cardiac disease. (Document No VU-07500) 26 September 2012 Efficacy and Safety Target Animal Safety Studies Applicant 55445 Page 6 of 7 Inherited Application No. KP25S_F39 Version: 2 Issued: 14/08/2007 Data No 71536 Data Source* S Author(s) P. Clausing and S. Muller Title Pimobendan ( UD-CG 115 BS): Subcutaneous and intravenous local tolerance study in beagle dogs. Doc No U07-1096 Date Data Type Data Sub-type Authorising Party 2007 Efficacy and Safety Target Animal Safety Studies Applicant Inherited Application No. * S = Data submitted with the application I = Data inherited (that is, referenced) from another application 55445 Page 7 of 7 KP25S_F39 Version: 2 Issued: 14/08/2007