March 10, 2023

Esperion Therapeutics Cholesterol Drug Issue with FDA


Esperion Therapeutics Cholesterol Drug

Esperion Therapeutics, Inc. is a public, American pharmaceutical company focused on the development of a first-in-class, orally available, small molecule designed to significantly lower elevated levels of LDL-C – with the reduced potential for muscle-related side effects associated with statin use.

Esperion Therapeutics Cholesterol Drug
Esperion Therapeutics Cholesterol Drug Issue

Company Overview

Esperion is a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol lowering therapies for the treatment of patients with elevated LDL-C. patients with elevated LDL-C have LDL-C levels not adequately controlled with current lipid-modifying therapies. Patients with elevated LDL-C only able to tolerate less than the lowest approved daily starting dose of a statin can be considered having statin intolerance.

Esperion Slumps on Lack of FDA Clarity for Cholesterol Drug

Esperion Therapeutics Inc. slumped as much as 29 percent in late trading after saying its experimental drug may not win Food and Drug Administration approval based solely on its ability to cut cholesterol, raising concerns it may take six more years to reach the U.S. market. The drugmaker said the FDA wouldn’t provide it with clarity on whether proof that the drug lowers bad cholesterol, known as low-density lipoprotein, or LDL, will be enough to get access to the U.S. market.

Global Cardiovascular Outcomes Trial in Bempedoic Acid

Esperion Therapeutics Inc announced the initiation of the global cardiovascular outcomes trial to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered statin intolerant. The start of the CLEAR Outcomes CVOT is one of the last and most exciting steps in the development of bempedoic acid, and we are very pleased to have begun dosing patients, said Tim M. Mayleben, president and chief executive officer of Esperion.

Can Esperion Therapeutics Ever Regain Wall Street’s Trust

Esperion Therapeutics is developing a new drug that it says can lower LDL cholesterol, the bad kind associated with heart attacks, by 30%. But shares have fallen from a high of $98 last August to just $10 this morning as the regulatory future for its drug becomes increasingly muddy. It would be enough to do just show that the drug lowered cholesterol in patients who could not take the gold standard for cholesterol treatment, statins, due to side effects, with the big study to come later.

FDA Removes Partial Clinical Hold For Esperion’s Drug for Bad Cholesterol

Esperion Therapeutics surged as high as 20% in today’s trading session after the company announced that it had received notice from the FDA that the partial clinical hold had been removed for their drug candidate ECT-1002.
Esperion is a biotechnology company focused on creating treatments for cardiometabolic risk factors. Primarily the company has an advanced drug candidate ECT-1002 that treats low-density lipoprotein cholesterol or LDL-C.

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