Esperion says FDA won't commit to surrogate endpoint

Esperion Therapeutics Inc. (NASDAQ:ESPR) lost $4.40 (27%) to $11.78 in early after-hours trading Tuesday after it said FDA "did not provide clarity on a regulatory pathway" in dialogue with the company about an LDL-C lowering indication for bempedoic acid ( ETC-1002) in statin-intolerant patients. The company hopes to use LDL-C lowering as a surrogate endpoint in Phase III studies of the hypercholesterolemia candidate.

Esperion said that if FDA does not accept LDL-C as a surrogate endpoint, it could submit an NDA for a CV disease risk reduction indication as late as 2022, after a CV outcomes trial (CVOT) is completed. ...