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KYNAPID ™ (vernakalant hydrochloride injection) Cardiovascular and Renal Drugs Advisory Committee

KYNAPID ™ (vernakalant hydrochloride injection) Cardiovascular and Renal Drugs Advisory Committee. Astellas Pharma US, Inc. December 11, 2007. Introduction. Donald Raineri, Pharm.D. Senior Director, Regulatory Affairs Astellas Pharma US, Inc.

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KYNAPID ™ (vernakalant hydrochloride injection) Cardiovascular and Renal Drugs Advisory Committee

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  1. KYNAPID™(vernakalant hydrochloride injection)Cardiovascular and Renal DrugsAdvisory Committee Astellas Pharma US, Inc. December 11, 2007

  2. Introduction Donald Raineri, Pharm.D. Senior Director, Regulatory AffairsAstellas Pharma US, Inc.

  3. Proposed Indication:Vernakalant injectionis indicated for the rapid conversion of atrial fibrillation of ≤ 7 days duration to sinus rhythm. Dosage and Administration: The initial infusion of vernakalant injection is 3 mg/kg infused over 10 minutes. If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered. Vernakalant Injection

  4. Key Attributes ofVernakalant Injection • Effective and rapid conversion of AF to sinus rhythm with reduction of AF symptoms • Durability of sinus rhythm out to 24 hours • Concomitant use with rate or rhythm control medications without affecting safety or efficacy • Well-characterized safety profile • Favorable risk-benefit profile • An important treatment alternative for patients with symptomatic atrial fibrillation

  5. Today’s Agenda

  6. Expert Consultants • David Fedida, M.D., Ph.D. Professor and Associate Head, Anesthesiology, Pharmacology and Therapeutics – University of British Columbia • Peter R. Kowey, M.D. President of the Main Line Health Heart Center William Wikoff Smith Chair in Cardiovascular Research Professor of Medicine and Clinical Pharmacology Jefferson Medical College • Craig Pratt, M.D. Director, Coronary Intensive Care Unit The Methodist DeBakey Heart Center, The Methodist Hospital • Edward L.C. Pritchett, M.D. Consulting Professor of Medicine Duke University Medical Center • Jeremy N. Ruskin, M.D. Director, Cardiac Arrhythmia Services Massachusetts General Hospital

  7. Astellas and Cardiome Experts Astellas Representatives: Marlowe Schneidkraut, Ph.D., DABTAssociate Director, Toxicology Jeen Liu, Ph.D.Director, Clinical Statistics Cardiome Representative: Garth Dickinson, M.D., FRCPCMedical Consultant Brian Mangal, MScDirector of Biostatistics

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