Dr. Ahmed
FDA Broadens LDL-C Lowering Indications for Esperion’s NEXLETOL and NEXLIZET Tablets. The approval was announced on 13th December, 2023.
Nexletol is the brand name of Bempedoic acid. Nexlizet contains Bempedoic acid plus Ezetemib.
The drug was initially approved in 2020 for the treatment of adults with heterozygous familial hypercholesterolemia who were already taking maximally tolerated statin therapy or required additional LDL-lowering therapy [Ref].
FDA Updates Nexletol Indications: Key highlights
- Esperion has received FDA approval for an updated indication for NEXLETOL and NEXLIZET, expanding their use to include the treatment of primary hyperlipidemia. This modification is effective immediately.
- The update removes the maximally tolerated qualifier for statin use and eliminates the prior limitation stating that the impact of NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality had not been determined.
- Labeling changes won’t impact the expected approval in Q1 2024 for cardiovascular risk reduction indications. The approval is based on CLEAR Outcomes trial data showing that Bempedoic acid in NEXLETOL and NEXLIZET significantly reduces cardiovascular risk.
Esperion has received FDA approval for an updated indication concerning LDL-cholesterol reduction in NEXLETOL and NEXLIZET, now extending to the treatment of primary hyperlipidemia within existing approved populations.
The FDA’s actions align with Esperion’s ongoing efforts to enhance treatment options for individuals with hyperlipidemia.
Sheldon Koenig, President and CEO of Esperion, expressed,
“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.”
The rules for using statins have changed, and restrictions on the heart-related effects of NEXLIZET or NEXLETOL have been lifted.
This update is part of the FDA’s effort to update drug labels, and it shows that Esperion is expanding the use of its medications.
This approval is immediately effective, and the drugs can be used for the mentioned conditions.
The company views these changes as a confirmation of NEXLETOL and NEXLIZET’s effectiveness and safety.
It is crucial to note that these modifications don’t affect the expected complete approvals for reducing cardiovascular risk, anticipated by the first quarter of 2024, relying on the data from the CLEAR Outcomes trial.
Furthermore, this trial demonstrated the significant cardiovascular risk reduction capabilities of Bempedoic acid, present in both NEXLETOL and NEXLIZET.
Esperion announced the FDA’s approval in a press release on 13th December. [ref]
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What are NEXLETOL and NEXLIZET?
Bempedoic acid (Nexletol) is a prescription medicine intended for adults who require further reduction of LDL cholesterol (LDL-C) and have either heterozygous familial hypercholesterolemia (HeFH), an inherited condition leading to elevated LDL-C levels, or known cardiovascular disease. It is used in conjunction with diet and other lipid-lowering medications.
Nexlizet is a medication that combines Bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor, and ezetimibe, a cholesterol absorption inhibitor.
It is prescribed as an additional treatment to diet and the maximum statin therapy tolerated by adults with either heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who need further reduction of low-density lipoprotein cholesterol (LDL-C).
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