Esperion’s cholesterol drug clears the last big safety hurdle, turning the corner to the FDA — now the big challenge looms
Esperion $ESPR looks set to make the final step in its long journey toward a marketing application at the FDA, with good odds of success next year. But the latest batch of positive safety and efficacy data won’t dispel the persistent questions over its sales strategy.
That’s going to take some hard dollar numbers.
First, the trial data.
The drug arm saw a moderate drop in LDL of 18% with a 19% cut in high-sensitivity C-reactive protein. That fits in well with what we’ve seen before in a string of Esperion studies, with the therapy fitting neatly between the generics that dominate the market and the PCSK9s that have had trouble finding traction, spurring some deep discounting that could spell trouble for Esperion.
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