BEMPEDOIC ACID BEMPEDOIC ACID WITH EZETIMIBE

Information current as at: 1 June 2026

PBAC meeting date: July 2026
Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Nexletol®
  • Nexlizet®
Form and strength:
  • Tablet 180mg
  • Tablet 180mg bempedoic acid with 10 mg ezetimibe
Submission sponsor:
SEQIRUS (AUSTRALIA) PTY LTD
Condition/indication:
(therapeutic use)
  • Hypercholesterolaemia
Listing requested:
To request listing of bempedoic acid, as monotherapy and in combination with ezetimibe, for the treatment of adult patients with hypercholesterolaemia (heterozygous familial and non-familial) at high risk of a first cardiovascular event or with established symptomatic atherosclerotic cardiovascular disease who have statin intolerance or are on maximally tolerated statin therapy, and despite treatment with ezetimibe, continue to have low-density lipoprotein cholesterol (LDL-C) levels greater than 1.8 mmol/L.
Funding program:
PBS General Schedule
Request authority level:
Authority Required (STREAMLINED)
PBAC Submission type:
New PBS listing (–)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
July 2026 PBAC meeting
Opportunity for consumer comment:
Open 25/03/2026 and close 20/05/2026 (see PBS Website)
3PBAC meeting:
Has not yet occurred
4PBAC outcome published:
Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:
Has not yet commenced
7Government processes:
Has not yet commenced
8Medicine listed on the PBS:
Has not yet occurred

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information

Case ID
1214
Page last updated
31 May 2026
v.9.19