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Phase III Boost For Esperion But Does It Own Its Destiny?

 
• By Sukaina Virji

Esperion will be allowed to enroll patients on high dose statins into the Phase III pivotal trial of its cholesterol lowering drug bempedoic acid, but with competing products ahead in the race, the product faces an uphill battle for market share even if it does garner approval.

Esperion Therapeutics Inc.'s global pivotal Phase III LDL-C lowering clinical development program of bempedoic acid will include patients with hypercholesterolemia on any statin at any dose based on positive top-line results from its Phase II pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase I and Phase II studies.

"With the positive clinical results of bempedoic acid added to high-dose statins, and following engagement with global regulatory agencies, we are pleased to include in our ongoing global Phase III...

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