Esperion notched major back-to-back FDA wins in February with its cholesterol-busting duo Nexletol and Nexlizet. Now, with physicians largely unfamiliar with the drugs, the company is hoping new clinical data will help build confidence as both prepare to hit the market.
In multiple phase 3 trials, Esperion's Nexletol significantly lowered (PDF) levels of high-sensitivity C-reactive protein in patients with abnormally high triglyceride levels whether they were actively taking standard-of-care statins or not, according to a pooled data analysis presented Saturday at the American College of Cardiology scientific sessions.
In patients whose protein levels measured above a baseline marker––a sign of inflammation––Nexletol lowered those levels by 42% at 12 weeks, Esperion said in a release. Nexletol significantly cut those levels whether or not patients were taking statins and regardless of the intensity of statins they received.
In a separate analysis, Nexletol significantly lowered levels of LDL-C and other lipids regardless of whether patients were treated with a drug alongside cholesterol buster ezitimibe.
The new analyses may help prescribers grow more comfortable with soon-to-hit-the-market Nexletol, a cholesterol fighter that nabbed an FDA approval in late February to lower LDL-C levels in patients with abnormally high cholesterol levels or an established CV disease who had reached maximum statin tolerance. The drug is expected to start distribution March 30.
The FDA based its approval on data from the Nexletol clinical program, including four late-stage trials showing the drug topped placebo by 18% in reducing LDL-C in patients treated with moderate- or high-intensity statins.
The same month, Esperion also received the FDA's nod for its cholesterol-lowering combo Nexlizet. The drug, a marriage of Esperion's bempedoic acid and ezetimibe, was evaluated on phase 3 clinical study data showing Nexlizet lowered LDL-C by 38% over placebo.
While Nexlizet currently has a Nexletol-matching FDA approval and won't hit market until July, Esperion already has its sights set on a bigger patient population.
On Saturday, Esperion released new phase 2 data showing Nexlizet cut LDL-C levels by 40% over placebo in patients with high cholesterol and Type 2 diabetes. The drug also lowered high-sensitivity C-reactive protein by 25% over baseline and showed no worsening in glycemic control in patients.
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 that of PCSK9 meds Repatha from Amgen and Praluent from Sanofi and Regeneron.
In a call with analysts in February, Chief Commercial Officer Mark Glickman said Nexletol will act as a springboard of sorts for Nexlizet 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 commercially available.