GE Healthcare ($GE) won an expanded FDA approval for one of its signature molecular imaging agents. AdreView can now be used to measure cardiac nerve activity to assess the risk of death in patients with heart failure.
Previously, AdreView's indication allowed clinicians to use it to detect a form of adrenal cancer and also brain cancer, in conjunction with other diagnostic tests.
This expanded approval is a major business win for the company. After all, expanded indications for a given device or imaging agent open the door to a much larger patient population and greater revenue. But this also gives doctors another vital tool to aid in the assessment and treatment of heart-failure patients. And it helps provide a more precise way to track progression of heart failure and perhaps intervene sooner with targeted treatments. The condition is a huge drain on the nation's healthcare system, costing $32 billion and currently affecting 5.1 million Americans, GE notes.
There's some novelty too in the latest approval. GE is now touting AdreView as "the first and only FDA approved molecular imaging agent" designed to link nerve function in a patient's heart to risk of death. Specifically, the indication allows its use to gauge cardiac nerve activity in patients with Class II or Class III heart failure, as defined by the New York Heart Association, and also left ventricular ejection fraction equal to or less than 35%. It helps assess neuronal capacity to upload and store norepinephrine, which can be depleted in heart failure patients as myocardial nerve activity increases and left ventricular function declines.
A multicenter international trial involving 985 heart failure patients helped back GE Healthcare's application for expanded FDA approval. As a control, 110 patients without heart disease also received an AdreView dose.
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