Esperion Notches 2nd FDA Approval With Cholesterol-Lowering Combo Nexlizet

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, 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.

In a call with analysts Thursday, Chief Commercial Officer Mark Glickman said Nexletol, which is expected to be commercially available March 30, will be a springboard of sorts for Nexlizet’s later launch for physicians unfamiliar with the drugs’ mechanism of action.

“I think the sequence, allowing physicians to become comfortable on one aspect of the bempdedoic acid piece, is important for both drugs,” Glickman said.

Answering concerns that both drugs might offset one another’s sales in the same market, Glickman said the company wasn’t concerned with any “cannibalization,” arguing physicians would likely start patients on Nexletol and mature them onto Nexlizet after the drug becomes available commercially in July.

Both drugs will rely on Esperion’s 300-rep strong sales team with an additional 30 regional directors, Glickman said. Esperion said about 270 of those territory managers have already accepted their offers.

In August, a phase 2 trial of Nexlizet showed no worsening of glycemic control after 12 weeks in patients with high cholesterol and Type 2 diabetes, Esperion said. The drug also nailed a key co-primary endpoint, reducing LDL-C by 40% over placebo.

The trial also linked the combo to a 25% reduction in high-sensitivity C-reactive protein and a clean safety profile, the drugmaker said.-Fierce Pharma

Share this:

Related Post

Stay Updated on Medical Equipment and Devices industry.
Receive our Daily Newsletter.