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Esperion Says FDA On Board With Filing Strategy For Bempedoic Acid

 
• By Emily Hayes

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.

Esperion Therapeutics Inc. says FDA is on board with its plans to file bempedoic acid for LDL-lowering in high risk patients with its current Phase III program, eliminating lingering concerns that it would need cardiovascular outcomes data for submission and potentially giving them a differentiating claim for statin-intolerant patients.

Bempedoic acid (ETC-1002) is an oral inhibitor of ATP citrate lyase, an enzyme on the cholesterol biosynthesis pathway, that the company has been positioning as a drug that works in a similar way as statins but with better tolerability, such as fewer muscle pain effects, due to more liver-specific activity

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