Esperion's LDL-Cholesterol Drug To Follow PCSK9 Inhibitor Approval Pathway
This article was originally published in The Pink Sheet Daily
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.
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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.
With a well-defined mechanism of action and positive post hoc outcomes data, PCSK9 inhibitors possess a profile that raises the bar for other non-statin classes – CETP in particular.
The recently public company completed Phase IIa studies for lead candidate ETC-1002 and intends to complete a pair of Phase IIb studies before year-end.