Another drug with the potential to lower cholesterol beyond maximally tolerated statin therapy is preparing to enter the marketplace, STAT reported on Oct. 28.
Esperion Therapeutics announced that its drug, bempedoic acid, lowered LDL cholesterol by an additional 18 percent over a 12-week period when added to statin treatment in a 779-patient study. Notably, it wasn’t associated with a higher rate of adverse events than placebo medication. Esperion plans to submit all its data to the FDA next year, with market approval targeted for 2020, according to the report.
The LDL cholesterol reduction associated with bempedoic acid is less than that achieved by PCSK9 inhibitors, another class of lipid-lowering drugs that is proven in terms of efficacy but remains underused because of high prices and burdensome preauthorization requirements. The manufacturers of two approved PCSK9 inhibitors have recently announced plans to slash their list prices, with Amgen saying just last week it would cut the price of evolocumab (Repatha) by almost 60 percent to $5,850 annually.
Even with deals in place to more than halve the list prices of evolocumab and alirocumab (Praluent), Esperion hopes the lower price of its drug will help will help it find a place in the market. The company plans to set a list price of $3,500 for bempedoic acid, according to STAT.
“There are 13 million people in the U.S. that have elevated LDL cholesterol and have had a cardiovascular event and need more cholesterol lowering,” Esperion CEO Tim Mayleben told the outlet. “The fact that the price of PCSK9s is being lowered, that’s great. But it’s still almost twice the list price of our drug.”
But a cardiologist who wasn’t involved in the studies of bempedoic acid struggled to envision room for the new drug, considering dirt-cheap generic statins are available to most patients and a more effective—albeit more expensive—class of drugs is already on the market for those with stubbornly high cholesterol levels.
“If you’re a marketer, I don’t know where you aim your gun at this one,” said Ethan Weiss, MD, with the University of California, San Francisco.
Read the full story from STAT below: