PCSK9 Sponsors May See Opportunity In Off-Label Promotion Court Case
With robust data on LDL-cholesterol lowering, sponsors of Praluent and Repatha could approach FDA with statements about broader use in lower risk patients, even before cardiovascular outcomes trials complete.
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The pricing advantage that might have been available to Praluent as first-in-class is undercut by the fact that it only has about a month’s lead time over the competition.
Reading The Praluent Tea Leaves Ahead Of Repatha's Approval
The label of Amgen's PCSK9 inhibitor is likely to look similar to that of Praluent, albeit with the addition of a claim for heterozygous familial hypercholesterolemia.
FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.