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Australian Public Assessment Report for Dronedarone Hydrochloride

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Australian Public Assessment Report for Dronedarone Hydrochloride Australian Public Assessment Report for Dronedarone Hydrochloride Proprietary Product Name: Multaq, Dronedarone Winthrop, Dronedarone Sanofi Submission No: PM-2008-3045-3 Sponsor: Sanofi Aventis Australia Pty Ltd October 2010 Contents I. Introduction to Product Submission........................................................................3 Submission Details.................................................................................................................. 3 Product Background................................................................................................................ 3 Regulatory Status .................................................................................................................... 4 Product Information ................................................................................................................ 4 II. Quality Findings.........................................................................................................4 Drug Substance (active ingredient)......................................................................................... 4 Drug Product........................................................................................................................... 5 Bioavailability......................................................................................................................... 5 Quality Summary and Conclusions......................................................................................... 7 III. Nonclinical Findings ..................................................................................................7 Introduction............................................................................................................................. 7 Pharmacology.......................................................................................................................... 8 Pharmacokinetics and Relative Exposures.............................................................................. 9 Toxicology ............................................................................................................................ 11 Nonclinical Summary and Conclusions................................................................................ 16 IV. Clinical Findings ......................................................................................................16 Introduction........................................................................................................................... 16 Pharmacokinetics .................................................................................................................. 19 Drug Interactions................................................................................................................... 28 Pharmacodynamics ............................................................................................................... 32 Efficacy ................................................................................................................................. 35 Safety .................................................................................................................................... 50 Clinical Summary and Conclusions...................................................................................... 71 V. Pharmacovigilance Findings...................................................................................80 VI. Overall Conclusion and Risk/Benefit Assessment ................................................81 Quality................................................................................................................................... 81 Nonclinical............................................................................................................................ 82 Clinical.................................................................................................................................. 82 Initial Risk-Benefit Analysis................................................................................................. 85 Further Risk-Benefit Analysis............................................................................................... 92 Outcome................................................................................................................................ 99 Attachment 1. Product Information ............................................................................100 AusPAR Multaq/Dronedarone Winthrop/Dronedarone Sanofi Dronedarone Hydrochloride Sanofi Aventis Australia Pty LtdPM- 2008-3045-3 Final 5 October 2010 Page 2 of 115 I. Introduction to Product Submission Submission Details Type of Submission New Chemical Entity Decision: Approved Date of Decision: 19 July 2010 Active ingredient(s): Dronedarone hydrochloride Product Name(s): Multaq, Dronedarone Winthrop, Dronedarone Sanofi Sponsor’s Name and Sanofi-Aventis Australia Address: 12-24 Talavera Road Macquarie Park NSW 2113 Dose form(s): Film coated tablets Strength(s): 400 mg Container(s): PVC//Al blister packs and HDPE bottles Pack size(s): 20, 50, 60, 100, 200 and 500 tablets Approved Therapeutic use: To reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted, on top of standard therapy. Route(s) of administration: oral Dosage: 400 mg twice daily with meals ARTG Number (s): 156356, 156373, 156374, 156379, 156385, 156386 Product Background Dronedarone is a benzofuran derivative that has been developed to overcome the use limiting iodine-associated adverse effects of the commonly used antiarrhythmic drug, amiodarone, with which it is structurally related. Dronedarone inhibits transmembrane Na+, K+, Ca2+, and L-type calcium currents and is also an antagonist at alpha- and beta-adrenoceptors but, unlike amiodarone, has little effect at thyroid receptors. It is one of a number of analogues of amiodarone being developed with the aim of avoiding the significant extracardiac side effects of amiodarone itself. Dronedarone was developed as an anti-arrhythmic agent for the first line treatment of atrial fibrillation and atrial flutter. It is structurally related to amiodarone but lacks the iodine component. It exhibits electrophysiological properties from all four Vaughan-Williams classes of antiarrhythmic agents with multiple ion channel blocking including inhibiting potassium currents (Class III), sodium currents (Class Ib) and calcium currents (Class IV). It also on-competitively antagonises beta adrenergic activity (Class II). It is less lipophilic than amiodarone, has a much smaller volume of distribution, and has an elimination half-life of about 24 hours, which contrasts to amiodarone's half-life of several weeks. As a result of these pharmacokinetic characteristics, dronedarone dosing is said to be less complicated than with amiodarone. Treatments used for rhythm control in atrial fibrillation (AF) include electrical cardioversion or drug conversion using amiodarone, flecainide or sotalol. Atrial flutter generally uses electrical AusPAR Multaq/Dronedarone Winthrop/Dronedarone Sanofi Dronedarone Hydrochloride Sanofi Aventis Australia Pty LtdPM- 2008-3045-3 Final 5 October 2010 Page 3 of 115 cardioversion and similar pharmacotherapeutics. Treatments used for rate control include digoxin, atenolol, metoprolol, diltiazem and verapamil. Treatment for thromboembolic complications involves anti-coagulation. The proposed tablets contain 400 mg dronedarone present as the hydrochloride salt, are film coated and are not scored. The maximum daily dose is 800 mg given as 1 tablet in the morning and 1 in the evening, with meals. There are three proposed trade names containing dronedarone (Multaq, Dronedarone Sanofi and Dronedarone Winthrop) but the product will be referred to as Multaq for the remainder of this AusPAR. Multaq is indicated in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalisation. Regulatory Status Dronedarone has been approved in the USA in July 2009, Canada in August 2009, Switzerland in September 2009 and the European Union in November 2009. The data submitted in the USA, Europe and Canada are the same as the dataset in this submission and the submission has not been withdrawn, rejected or deferred in any country. USA Approved Indication: Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (that is, age >70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted [see Clinical Studies). Canada Approved Indication: Multaq is indicated for the treatment of patients with a history of, or current atrial fibrillation to reduce the risk of cardiovascular hospitalization due to atrial fibrillation (see Clinical Trials). Europe Approved indication: Multaq is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate (see section 5.1). Product Information
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