DEPEMOKIMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Exdensur®
- Form and strength:
-
- Solution for subcutaneous injection 100 mg in 1 mL
- Submission sponsor:
- GLAXOSMITHKLINE AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Uncontrolled severe eosinophilic asthma
- Listing requested:
- To request listing of depemokimab for the treatment of uncontrolled severe eosinophilic asthma in patients aged 12 years or older with a blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months, or with a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Written) for initial treatment Authority Required (STREAMLINED) for continuing treatment
- 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:
- 21/08/2026
-
Acceptance of complete documentation:
- Under consideration
-
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 listing of depemokimab for the treatment of uncontrolled severe eosinophilic asthma in patients aged 12 years or older.
The PBAC welcomed the input from healthcare professionals and organisations supporting the listing of depemokimab for this use. The comments emphasised the potential for depemokimab to help patients stay on treatment and make treatment easier to manage as it only needs to be given every 6 months. However, the PBAC also noted a possible concern that some people may think they do not need regular asthma check-ups because the medicine is given less often.
Based on the evidence included in the submission, the PBAC was satisfied that depemokimab
was as effective as mepolizumab at reducing asthma exacerbations and had similar safety.
The PBAC advised that the cost of depemokimab would be acceptable if it cost no more
than the least costly biologic for asthma over a 1-year time frame. The PBAC considered
the equi-effective doses for uncontrolled severe asthma were:
• DEPE 100 mg by subcutaneous (SC) injection 6 monthly (2 doses over one year);
• MEPO 100 mg by SC injection every 4 weeks (13 doses over 1 year).
The PBAC advised that the equi-effective doses for depemokimab and other biologics for asthma should be based on that previously accepted by the PBAC at the time those biologics were recommended.