Esperion Therapeutics Shares Explode After This FDA News

Esperion Therapeutics just released some news that has investors celebrating and its share price soaring.

The small biotech company has a medicine called bempadoic acid, which is intended to be used as an adjunct to statin therapy in patients with hypercholesterolemia. This is a state of high levels of cholesterol in the blood. Adjunct therapy is given in addition to the primary or initial therapy to maximize its effectiveness.

Esperion announced that the Food and Drug Administration has agreed that the company’s medicine, bempadoic acid, could be approved based on blood test results, before a larger study proving it prevents heart attacks, strokes, heart procedures or deaths has been completed.

Previously the company thought the FDA may not approve the drug until the larger study was completed.

Safety and tolerability study results are expected by the second quarter of 2018 while the results for assessing bempdeoic acid’s ability to lower LDL-C will available by mid-2018.

While Esperion doesn’t have a formal agreement, known as a special protocol assessment, on its cholesterol studies, a spokesman says that the company does have the written meeting minutes from its communication with the FDA.

The company plans to file a New Drug Application (NDA) with the FDA by the first quarter of 2019, subject to successful completion of an ongoing Phase 3 trial.

“We continue to believe that bempedoic acid has the potential to provide physicians with a complementary and convenient oral treatment option that’s cost-effective for their patients with hypercholesterolemia who require additional LDL-C lowering,” said Tim M. Mayleben, president and chief executive officer of Esperion.

Disclaimer: We have no position in Esperian Therapeutics Inc. (NASDAQ: ESPR) and have not been compensated for this article.