A small pharmaceutical company is seeking government approval for a cholesterol medication cheaper than many top treatments.
The Centers for Disease Control and Prevention (CDCP) reports that 102 million adults have “bad” cholesterol at or above healthy levels and 35 million are at risk of heart disease. Treating high cholesterol levels can be expensive, although a new drug by Esperion Pharmaceutical may provide a cheaper alternative.
Recently, the company’s cholesterol-lowering drug, bempedoic acid, passed its fifth and final trial. Esperion will submit bempedoic acid’s application for approval to the Food and Drug Administration (FDA) in early 2019.
A 12-week treatment of the drug paired with statins, another cholesterol drug, was found to lower LDL cholesterol 18 percent more than a treatment of only statins. A separate trial produced a reduction of 32 percent compared to a treatment of only statins.
According to MedlinePlus, LDL cholesterol is known as the “bad” cholesterol because it can build up in arteries, forming, along with other substances, plaque. Various heart and artery-related diseases can result from high levels of LDL cholesterol.
Previous trials of bempedoic acid returned less promising results. In one, the effects of a placebo were indistinguishable from bempedoic acid among nearly 800 test subjects. Another test involving more than 2,200 subjects found more subjects died while taking bempedoic acid than did those taking the placebo.
Bill Sasiela, head of clinical development at Biotech, a company involved in the study, thought that deaths from the larger round were not out of the ordinary.
“[G]iven the high-risk patient population, this is actually an overall number of events of about what you’d expect,” he said.
Others argue that the more recent tests have addressed concerns from earlier trials.
“From my perspective, I think the noise around those imbalances [from the earlier trials] should not be overestimated in importance,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has served as an unpaid investigator of bempedoic acid. “I certainly don’t think it’s a regulatory issue at this point.”
Esperion is hoping to make in-roads against other cholesterol pharmaceuticals by undercutting their prices.
Cholesterol treatment drugs, Praluent and Repatha (both PCSK9 inhibitors), arrived to market costing more than $14,000 annually, according to Biopharma Dive. Esperion’s bempedoic acid is expected to cost $3,500 a year.
Earlier this year, however, Praluent’s and Repatha’s prices were cut significantly — Praluent to between $4,500 and $8,000 a year, Repatha to $5,850.
Some health professionals have expressed skepticism that bempedoic acid will be able to compete against Praluent and Repatha now that its competitors have slashed prices.
“I’m still not totally convinced that there’s an obvious place for this drug,” said Dr. Ethan Weiss, a cardiologist at the University of California, San Francisco Medical Center. “We have a good drug with modest efficacy in statins, and then two drugs with significant efficacy in PCSK9. If you’re a marketer, I don’t know where you aim your gun at this one.”
However, Esperion is optimistic that bempedoic acid could help more people with high cholesterol. Esperion CEO Tim Mayleben pointed out that only 20,000 people take PCSK9 treatments.
“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,” Mayleben said. “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.”
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