Esperion Therapeutics Inc. (ESPR) said the Food And Drug Administration (FDA) has confirmed that its low-density lipoprotein cholesterol (LDL-C) lowering program is adequate to support approval of an LDL-C lowering indication for the company’s drug candidate bempedoic acid. (See also, New-Age Cholesterol Drugs Don't Sell.)
The Ann Arbor, Michigan-based company, which develops and commercializes treatments for LDL-C patients, 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. Esperion also plans to file a Marketing Authorization Application with the European Medicines Agency (EMA) around the same time.
The Phase 3 program comprises four different studies, each having varying symptoms in the patient population. The variation in the four different studies include patients with hypercholesterolemia, which is high levels of cholesterol in the blood, those who can tolerate less than the lowest approved daily starting dose of statin, those who are considered “statin-intolerant,” and those who are taking a low dose of statin with ezetimibe. Statins are drugs that can lower cholesterol.
Esperion's drug, bempedoic acid, is intended to be used as an adjunct to statin therapy in patients with hypercholesterolemia, 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.
Preliminary Results Expected in Mid-2018
While safety and tolerability study results are expected by the second quarter of 2018, the results for assessing drug’s ability to lower LDL-C will available by mid-2018.
“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.
During earlier studies, the drug decreased cholesterol biosynthesis and brought down higher levels of LDL-C, and was also believed to potentially decrease the occurrence of muscle-related side effects.
Following the positive update, Esperion's stock opened at $33.95 per share, up 45% compared to the previous day’s close. (See also, Amgen's Repatha Cut Stroke, Heart Attack Risk.)