PEGCETACOPLAN

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:
  • Empaveli®
Form and strength:
  • Solution for subcutaneous infusion 1,080 mg in 20 mL
Submission sponsor:
SWEDISH ORPHAN BIOVITRUM PTY LTD
Condition/indication:
(therapeutic use)
  • Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN)
Listing requested:
Resubmission to request listing of pegcetacoplan for the treatment of patients aged 12 years and older with C3G or primary IC-MPGN.
Funding program:
PBS Section 100 (Highly Specialised Drugs Program)
Request authority level:
Authority Required (Written)
PBAC Submission type:
Change to existing 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
Glossary

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information
Case ID
1254
Page last updated
31 May 2026
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