FDA approves expanded indications for bempedoic acid and combination tablet
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Key takeaways:
- The FDA approved expanded indications for bempedoic acid and bempedoic acid plus ezetimibe for primary hyperlipidemia.
- The prerequisite for patients to already be on maximally tolerated statins was removed.
Esperion announced the FDA granted an updated indication for bempedoic acid and bempedoic acid plus ezetimibe for the treatment of primary hyperlipidemia in eligible patients with genetic hyperlipidemia or atherosclerotic CVD.
Additionally, the prerequisite for patients to already be on maximally tolerated statin therapy has been removed for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet), and the note of their indeterminate effect on CV morbidity and mortality has been removed, according to a company press release.
These labeling modifications do not impact the full pending label approvals for CV risk reduction with bempedoic acid and bempedoic acid/ezetimibe, for which the FDA issued a PDUFA date of March 31, 2024, according to the release.
“We are pleased that the FDA has approved these modifications to our current indications for Nexletol and Nexlizet, which reinforce the proven efficacy and safety of these treatments,” Sheldon Koenig, president and CEO of Esperion, said in the release.
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