APADAMTASE ALFA / CINAXADAMTASE ALFA
Information current as at: 1 June 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- Adzynma®
- Form and strength:
-
- Injection set containing powder for injection 500 units and solvent 5 mL
- Injection set containing powder for injection 1,500 units and solvent 5 mL
- Submission sponsor:
- TAKEDA PHARMACEUTICALS AUSTRALIA PTY. LTD.
- Condition/indication:
(therapeutic use) -
- Congenital thrombotic thrombocytopenic purpura (cTTP)
- Listing requested:
- To request listing of apadamtase alfa / cinaxadamtase alfa (an enzyme replacement therapy) for the prevention of acute events in adult and paediatric patients with chronic, severe cTTP who have a confirmed ADAMTS13 genetic mutation and ADAMTS13 activity levels less than 10% and who cannot tolerate, or are hypersensitive to, preventative treatment with fresh frozen plasma.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- 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 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
Case ID
1210
Page last updated
31 May 2026
v.9.19