Esperion Says FDA On Board With Filing Strategy For Bempedoic Acid
Unlike Amgen's FOURIER study of Repatha, which disappointed investors with a lower magnitude of benefit than expected, Esperion's outcomes trial of bempedoic acid will be done in patients with higher baseline LDL and will be much longer.
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On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.
'Study 4' results may support a label claim related to reducing inflammation – measured through the high sensitivity C-reactive protein (hsCRP) marker – down the line, the company told investors.