DONIDALORSEN
Information current as at: 1 September 2026
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 (Category 2)
- 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)
-
PBAC meeting: - Held on 08/07/2026
-
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
The PBAC recommended donidalorsen for the prevention of recurrent attacks of hereditary angioedema (HAE) Types I and II.
The PBAC acknowledged input from individuals, health professionals and organisations which emphasised the value of an additional option for preventive treatment. The PBAC noted that patients may respond differently to different therapies and that the distinct mechanism of action, pre-filled pen device and potential for less frequent dosing with donidalorsen may support more individualised treatment.
The PBAC considered the clinical evidence and was satisfied that donidalorsen provides comparable effectiveness to lanadelumab and garadacimab at reducing the number of HAE attacks.
The PBAC considered that 80 mg every four weeks of donidalorsen would be equivalent to 300 mg every 4 weeks of lanadelumab. Further, the PBAC considered that, over two years, 2,087 mg of donidalorsen would be equivalent to 5,000 mg of garadacimab. The PBAC calculated the doses relative to garadacimab over a two-year period to account for the loading dose required for garadacimab.
The PBAC recommended flow-on changes to the restrictions for other PBS listed medicines that treat HAE (i.e. garadacimab and lanadelumab) to allow switching from donidalorsen to garadacimab or lanadelumab and to prevent combination use of these three medicines.
The PBAC advised that donidalorsen should join the existing lanadelumab risk sharing arrangement with similar arrangements to garadacimab.