Bempedoic acid receives broader indications from FDA
Click Here to Manage Email Alerts
Key takeaways:
- Bempedoic acid is now approved for MI prevention and LDL lowering in both primary and secondary prevention.
- The expanded indications include primary hyperlipidemia, with or without a statin.
Esperion Therapeutics announced the FDA approved broad label expansion for bempedoic acid and bempedoic acid/ezetimibe for CV risk reduction and LDL lowering in both primary and secondary prevention populations.
Additionally, the expanded indications for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) also include indications for primary hyperlipidemia — alone or in combination with a statin — and are the only nonstatin drugs indicated for primary prevention patients, according to a company press release.
The approvals are based on results of the CLEAR Outcomes trial that assessed the effect of bempedoic acid on CV outcomes in 13,970 adult patients with a history of CVD or at high risk deemed statin intolerant.
As Healio previously reported, bempedoic acid reduced risk for a composite of major adverse CV events, including CV death, nonfatal stroke, nonfatal MI and coronary revascularization, compared with placebo.
“We are pleased to receive approval for our highly anticipated label expansions in the U.S., which will enable more than 70 million patients to now be eligible for Nexletol and Nexlizet,” Sheldon Koenig, president and CEO of Esperion Therapeutics, said in the release. “Importantly, these approvals expand the accessibility of our highly effective drugs to primary prevention patients, or to those who are at high risk of having a cardiovascular event, but who have not yet had one. These approvals also eliminate the statin use requirement, allowing patients to take Nexletol or Nexlizet either with or without a statin, which significantly reduces previously existing prescribing limitations.”
Collapse
Click Here to Manage Email Alerts