FDA won't demand pre-approval CVOT from Esperion

Esperion Therapeutics Inc. (NASDAQ:ESPR) rose $7.99 (11%) to $83.50 in after-hours trading on Monday after it said FDA will not require a cardiovascular outcomes trial of ETC-1002 prior to approval for the company's proposed label indication.

Esperion is seeking an initial label as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) who require further LDL-cholesterol lowering after treatment with maximally tolerated statins. The company plans to begin a CVOT in late 2016 or early 2017 to support a broader label. ...