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FDA approves imaging drug for evaluation of myocardial ischemia and infarction

Action

The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia (cardiac function disorder when the heart muscle doesn’t receive enough blood flow to function properly) and infarction (heart attack). Flyrcado is a cyclotron-produced radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise).

Flyrcado is administered by intravenous injection.

Disease or Condition

CAD is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It is often caused by plaque buildup in these arteries. CAD is very common, impacting over 18 million adults in the U.S., and is the leading cause of death in the U.S.

Myocardial ischemia occurs when blood flow to the heart is reduced, often caused by partial or complete blockage of the coronary arteries. Myocardial ischemia reduces the heart’s ability to pump blood. A sudden blockage of one of the coronary arteries can lead to a heart attack. Approximately every 40 seconds, someone in the U.S. will have a heart attack.

Effectiveness

The efficacy and safety of Flyrcado were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected CAD (Study 1: NCT03354273) or known or suspected CAD (Study 2: NCT01347710). Study 1 evaluated the sensitivity (ability to designate an imaged patient with disease as positive) and specificity (ability to designate an imaged patient without disease as negative) of Flyrcado for the detection of significant CAD in subjects with suspected CAD who were scheduled for invasive coronary angiography (ICA). Across three Flyrcado imaging readers, estimates of sensitivity ranged from 74% to 89% and estimates of specificity ranged from 53% to 70% for CAD defined as at least 50% narrowing of an artery.

Study 2 evaluated the sensitivity and specificity of Flyrcado for the detection of significant CAD in subjects with known or suspected CAD who had ICA without intervention within 60 days prior to imaging or were scheduled for ICA. Across three Flyrcado imaging readers, estimates of sensitivity ranged from 63% to 77% and estimates of specificity ranged from 66% to 86% for CAD defined as at least 50% narrowing of an artery.

Safety Information

The most common adverse reactions (occurring in at least 2% of participants receiving Flyrcado for rest and stress imaging) were dyspnea (shortness of breath), headache, angina pectoris (severe pain in the chest), chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia (irregular heartbeat).

Exercise or pharmacologic stress itself is associated with risk of serious adverse reactions, including myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Healthcare professionals should perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, healthcare professionals should perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.

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