Esperion, aiming to reconfigure the cholesterol-lowering market, notched its first FDA approval last week for a novel drug expected to hit shelves at a rock-bottom price. Now, the company has its second green light for another cholesterol buster, and it's looking to take the pricing fight directly to its PCSK9 competitors.
Esperion notched its second FDA approval in as many weeks Wednesday with a green light for Nexlizet (bempedoic acid-ezetimibe) to lower LDL cholesterol in patients with high cholesterol or established atherosclerotic cardiovascular disease who have reached maximum-tolerated statin therapy, the company said.
The combo is now Esperion's second approved therapy in that indication after its Nexletol (bempedoic acid) monotherapy received the FDA's nod Friday.
Despite both drugs sharing an active ingredient, Nexlizet will tout more impressive data on its label after a phase 3 clinical study showed the drug lowered LDL-C by 38% over placebo. Nexletol, by contrast, posted an 18% reduction in its clinical program, including four late-stage trials in patients treated with moderate- or high-intensity statins. Both drugs were approved for patients who have reached their maximum statin tolerance, the company said.
Nexletol and Nexlizet will be sold at a wholesale acquisition cost of $10 per day, an Esperion spokesman said, a price the drugmaker said was far below PCSK9 meds like Amgen's Repatha and Sanofi and Regeneron's Praluent.
Hamstrung by payer pushback, Repatha and Praluent have been engaged in a long-running price war aimed at courting access as well as undercutting each other. In October, Amgen upped those stakes by slicing the tag for Repatha to $5,850––a price that matched Praluent to the dollar.