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Cardiovascular and Renal Drugs Advisory Committee

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Presentation on theme: "Cardiovascular and Renal Drugs Advisory Committee"— Presentation transcript:

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

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

3 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

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

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

6 ~ 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

7 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”

8 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

9 Animal Data: Species Considerations

10 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

11 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

12 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

13 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

14 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

15 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

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