Bempedoic acid regulatory update
Esperion said FDA “did not provide clarity on a regulatory pathway” about an LDL-C lowering indication for bempedoic acid in statin-intolerant patients. The company hopes to use LDL-C lowering as a surrogate endpoint in Phase III trials of the ATP citrate lyase (ACLY) inhibitor to treat hypercholesterolemia. Esperion said that if FDA does not accept LDL-C as a surrogate endpoint, it could submit an NDA for a cardiovascular disease risk reduction indication as late as 2022, after a cardiovascular outcomes trial (CVOT) is completed. Esperion said FDA was concerned about a shifting landscape in acceptable endpoints for cholesterol-lowering drugs, motivated by ongoing CVOTs for hypercholesterolemia treatments in other drug classes.
The company plans to start its international CLEAR Outcomes CVOT and international Phase III LDL-lowering trials in 4Q16. The event-driven CVOT plans to enroll about 12,600 statin-intolerant patients and continue for up to 5 years. ...