The European Commission has granted marketing authorisation for Itvisma, the intrathecal formulation of onasemnogene abeparvovec developed by Novartis, for the treatment of adults and children aged two years and older living with 5q spinal muscular atrophy (SMA).
This decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in April 2026 and marks another important step forward in the development of treatment options for the SMA community across Europe.
What does this mean for people in the UK?
Although this is welcome news, it is important to note that this European Commission approval does not apply to access in the UK.
Before Itvisma can become routinely available on the NHS, it must first receive approval from the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Following this, the National Institute for Health and Care Excellence (NICE) must assess the treatment to determine whether it should be recommended for use on the NHS in England.
The NICE committee is due to meet on 7 July, and we will continue to keep the SMA community updated as more information becomes available. At this stage, no decisions have been made about access to Itvisma in the UK.
Welcoming the European Commission’s decision, Nicole Gusset, CEO of SMA Europe, said:
“Every new treatment represents progress for the SMA community and brings renewed hope to people living with SMA and their families. We welcome the decision of the European Commission and, together with our members, will continue advocating for timely and equitable access across Europe, so that everyone who may benefit has the opportunity to do so.”
SMA Europe continues to work alongside its member organisations, healthcare professionals, industry partners and policymakers to support timely and equitable access to approved SMA treatments across Europe.
As national reimbursement and implementation processes begin, access to Itvisma will vary between countries. SMA Europe will continue to share updates as more information becomes available through its Access Hub.
We will continue to monitor developments in the UK and share updates with our community following the NICE committee meeting and any future MHRA and NICE decisions.
For more information, please find attached a letter from SMA Europe with further details.
For Novartis press release click here.
If you have any questions, please contact communications@sma-europe.eu.
