PEGVALIASE
Information current as at: 1 July 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- Palynziq®
- Form and strength:
-
Injection 2.5 mg in 0.5 mL pre-filled syringe
Injection 10 mg in 0.5 mL pre-filled syringe
Injection 20 mg in 1 mL pre-filled syringe - Submission sponsor:
- BIOMARIN PHARMACEUTICAL AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Phenylketonuria (PKU)
- Listing requested:
- Resubmission to request listing of pegvaliase for the treatment of patients aged 16 years and older with PKU who have inadequate blood phenylalanine control (baseline blood phenylalanine level above 600 micromoles per L) despite prior management with available treatment options (including a phenylalanine restricted diet and sapropterin). An inadequate response to a trial of sapropterin is defined as failure to achieve a 30 per cent or greater reduction in blood phenylalanine from baseline following initial treatment with sapropterin. The submission also seeks PBAC consideration for extending eligibility to patients aged 16 years and older with PKU who have a protein tolerance of less than 15 grams per day, even if sapropterin responsive. This item was previously considered by the PBAC at its March 2026 meeting.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New PBS listing (–)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (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
Not yet published
Case ID
1257
Page last updated
30 June 2026
v.9.19