Esperion rockets as FDA backs cholesterol drug for regulatory filing
US lipid management firm Esperion Therapeutics (Nasdaq: ESPR) leapt as much as 52% in morning trading today, after getting positive regulatory feedback on its cholesterol lowerer. The stock was still up 51.1% at $35.80 by late morning
The US Food and Drug Administration recently confirmed that Esperion’s low density lipoprotein cholesterol (LDL-C)-lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid, the company revealed this morning.
Esperion plans to submit a New Drug Application by first-half 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase III program. The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high cardiovascular disease (CVD) risk with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) who require additional LDL-C lowering.
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