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.
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.
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.