Esperion Expects Speedy Regulatory Path For Bempedoic Acid/Zetia Combo
Company plans to file the fixed-dose combination through FDA's 505(b)2 pathway, alongside a filing for bempedoic acid itself.
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Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.
On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.