AHA: Esperion's cholesterol-fighter Nexletol builds its case for a bigger market
Esperion's Nexletol notched an FDA approval in February. (Esperion)
With back-to-back approvals in February for its cholesterol-fighting flagship drugs, Esperion is aiming to take the fight right to its PCSK9 rivals. Now, Esperion is touting new subgroup data that could keep building the drugmaker's case with doctors.
Esperion's Nexletol cut bad cholesterol levels over placebo in patients who could not tolerate background statins, and women on the drug with preexisting cardiovascular disease showed greater benefits than men, according to analyses presented Friday at the American Heart Association virtual meeting.
Nexletol cut cholesterol by 26.5% over placebo at the 12-week mark with a comparable safety profile between the two arms, Esperion said. In the pool of patients who could not tolerate statins, women showed a numerically greater cholesterol reduction than men—27.7% to 22.1%—but those results weren't statistically significant.
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In a separate analysis looking at statin-treated men and women with preexisting cardiovascular disease, with or without abnormally high cholesterol levels, female patients saw a 21.2% reduction in cholesterol compared with 17.4% for men—data that came in just below the milestone significance p-value of 0.05.
The newest data, despite mixed results, could help Esperion take the fight to pricier PCSK9 drugs like Amgen's Repatha and Sanofi and Regeneron's Praluent.