Esperion Therapeutics Inc. had been working with the FDA in an attempt to forge a new regulatory path for its cholesterol drug ETC-1002 in statin-intolerant patients, a population the US agency has been very cautious about in the past.
The Ann Arbor, Michigan-based group had proposed a plan to conduct a Phase III study using LDL-C lowering as a surrogate, but still approvable, efficacy endpoint in statin-intolerant patients (Also see "Esperion Update On Lead Cholestrol Drug Spooks Investors" - Scrip, 30 September, 2015.)