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.
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Company says FDA confirmed that cardiovascular outcomes data will not be required for initial submission of ETC-1002 in patients with familial hypercholesterolemia and atherosclerotic CV disease; Esperion expects to start Phase III development by the end of 2015.
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.
Despite enthusiasm about PCSK9 class, the prescribing community will have to wrestle with patient-selection criteria, uncertainty about very low LDL levels and a lack of outcomes data for Sanofi and Regeneron’s alirocumab.