ONASEMNOGENE ABEPARVOVEC
Information current as at: 1 June 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- OAV101 IT®
- Form and strength:
-
- 1 vial solution for intrathecal injection 1.2 x 1014 vector genomes per mL, 3 mL
- Submission sponsor:
- NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Spinal muscular atrophy (SMA)
- Listing requested:
- To request listing of intrathecal onasemnogene abeparvovec for the treatment of symptomatic SMA in patients at least 2 years of age but yet to turn 19 years old who have experienced at least two of the defined signs and symptoms of SMA Type I, II or IIIa prior to 3 years of age.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- 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
PBAC Outcome
Case ID
1236
Page last updated
31 May 2026
v.9.19