A small biotech company has a shot at shaking up a market roosted by giants, moving toward approval with a pill it believes can lower bad cholesterol at a discount to other medicines.
On Sunday, Esperion Therapeutics said a combination of its once-a-day treatment and a maximum dose of statin lowered LDL cholesterol 18 percent more than statins alone after 12 weeks. The results come from the last of five successful trials on Esperion’s drug, called bempedoic acid. The company plans to submit all of its data to the Food and Drug Administration in the early months of 2019.
To cardiologists, the most important finding of the latest bempedoic acid trial related to safety. In the 779-patient study, Esperion’s drug was indistinguishable from placebo when it came to side effects and deaths. That’s important because, in an earlier trial involving more than 2,200 subjects, more patients getting bempedoic acid died than those getting placebo. The difference wasn’t big enough to rule out random chance, and none of the deaths was blamed on the drug, but it was enough to stoke concern that the FDA might think twice about approving Esperion’s treatment.
About the Author Reprints
Would like to know more about it
——– how about for guys who just can’t stand statins ? . . .