DONIDALORSEN

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:
  • Zirdawny®
Form and strength:
  • Solution for injection 80 mg in 0.8 mL pre-filled pen
Submission sponsor:
OTSUKA AUSTRALIA PHARMACEUTICAL PTY. LTD
Condition/indication:
(therapeutic use)
  • Hereditary angioedema
Listing requested:
To request listing of donidalorsen for the long-term prophylaxis (prevention) of recurrent attacks in patients with hereditary angioedema.
Funding program:
PBS General Schedule
Request authority level:
Authority Required (Written)
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
Glossary

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information
Case ID
1223
Page last updated
31 May 2026
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