Esperion Therapeutics, Inc, the lipid management company trying to develop a new cholesterol drug, has announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid and could be approved based on blood test results, before a larger study proving it prevents heart attacks, strokes, heart procedures or deaths has been completed.
This announcement should be considered a good news for the shareholders who where on the other side negatively surprised by Friday 17th march news when Esperion’s shares dropped 20% because Amgen’s cholesterol drug, Repatha, did less well at preventing heart problems than analysts at investment banks had forecast it would.
But few consideration must be taken on what happened on Friday when shareholders lineked Amgen’s result to the future of Esperion’s drug. Investors could have just decide to abandon heart drugs because of their not brialiant sales performance as Repatha and Entresto, a much-hyped heart failure drug from Novartis, even if nobody understand how come what used to be the drug industry’s biggest market has suddenly become infertile.
However what happened with Amgen data should not have a negative reflection on to what will happen with Esperion’s drug.
Firstofall Amgen’s Repatha underperformed in part because it had no effect on heart hospitalizations, as nowdays due to new, better blood tests, people hospitalized for chest pain are now more likely to have problems unrelated to heart disease so that’s why cholesterol drugs have no effect. However as explained by Tim Mayleben, Esperion’s chief executive, Esperion still has plenty of time to change the goal of its research.
Furthermore Esperion will have another advantage over Amgen’s drug: it will be a lot cheaper than comparable traditional cholesterol pills. And this bring us to antoher difference between Repatha and Esperion, one is an injectable drug the other is a pill.
Finally, Esperion’s study will also be composed of people with much higher cholesterol levels than the Amgen study.
The company plans to apply for approval by the first half of 2019. Also the company expexts to finish its study on heart problems and strokes by 2021.
Esperion’s initial approval would be in patients with high cardiovascular risk, particularly those with established coronary artery disease or familial hypercholesterolemia, a genetic disease that causes high cholesterol levels. If a study showed the drug reduced heart problems, that approval could be expanded.