Cardiovascular and Renal Drugs Advisory Committee

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Presentation transcript:

Cardiovascular and Renal Drugs Advisory Committee Safety Considerations in the Development of Ultrasound Contrast Agents June 24, 2008 Dwaine Rieves, MD

Cardiovascular and Renal Drugs Advisory Committee Introduction to Products AC Background AC Goals

Introduction to Ultrasound Contrast Agents (UCA): Core gas within molecular shell Generally < size of RBC Administered IV Larger bubbles embolize to lungs Other bubbles enter L heart Echogenic contrast

Ultrasound Contrast Agents (UCA) Approved use: LV chamber/endocardial border Potential approval goals: peripheral vessels vascularity in organs myocardial perfusion other?

Marketed Ultrasound Contrast Agents Optison (US): albumin + perflutren Definity (US): lipid + perflutren SonoVue (non-US): lipid + sulfur hexafluoride

~ 190 reports of patients with serious non-fatal events AC Background: 9/2007 US UCA ~ 190 reports of patients with serious non-fatal events hypotension dyspnea loss of consciousness/seizure arrhythmia/cardiac arrest other…urticaria, back pain 4 deaths within 30 minutes General pattern: underlying chronic conditions stress test acute “unstable” conditions

Other Background Considerations Optison (1997): off market since 11/2005 premarket safety database ~ 300 postmarket exposure (Premier) > 200 K Definity (2001): premarket safety database ~ 1700 “unstable” patients excluded postmarket exposure (Premier) > 260 K PMC to perform a surveillance study of Definity “as it is used in clinical practice”

Approved for echo, “macrovascular” and “microvascular” doppler SonoVue (2001, non-US): Approved for echo, “macrovascular” and “microvascular” doppler Three fatal AE prompted echo contraindications: acute MI or certain patients with angina acute or class 3/4 cardiac failure severe cardiac rhythm disorders severe pulmonary hypertension ARDS Arterial hypotension & PA hypertension in pigs pattern suggestive of clinical correlate

Animal Data: Species Considerations

Label Revisions: 9/2007 Boxed warning: Contraindications: serious cardiopulmonary reactions Contraindications: unstable/high risk patients Monitor all patients during & for 30 minutes post-test EKG/oxygen saturation

Following 9/2007 Label Revisions Physician concern re: contraindications monitoring plans Published data: no PA alterations in humans limited details Developed risk assessment & management plan (RMP) Update labels

Prior contraindications Monitoring focused on high risk patients RMP: 2008 Label Changes & RMP Altered boxed warning Prior contraindications Monitoring focused on high risk patients RMP: HCP education re: risks/usage New studies “required” under FDAAA Pulmonary hemodynamics Observational study of critically ill

Visibility/shared experience: AC Goals Visibility/shared experience: Sponsor summary of experience Identify “lessons learned” Stimulate discussion/education: Identify “essential” considerations for future preclinical & clinical development Anticipate future discussion of imaging products: Unique “efficacy” for diagnostics Unique study designs

We are not focusing upon: AC Concepts We are not focusing upon: any specific contrast agent any recommendations for specific regulatory action We are focusing upon shared: experiences from companies perspectives from AC members

Dr. Sanjiv Kaul: Clinical Dr. Robert Hamlin: Preclinical Agenda Dr. Sanjiv Kaul: Clinical Dr. Robert Hamlin: Preclinical Bracco Imaging: SonoVue Break GE Healthcare: Optison Lantheus Medical Imaging: Definity OPH FDA introduction to questions Discussion