EU Approves Novartis’ Itvisma for SMA as Dupilumab Sales Hit €10.7 Billion
NVS•European regulators approved Novartis’ Itvisma gene therapy for 5q spinal muscular atrophy patients aged two years and older, based on STEER trial gains of 2.39 HFM points over 52 weeks with a one-time intrathecal dose. Novartis’ Dupilumab achieved record €10.7 billion in 2023 sales and $4.34 billion in Q2 2025.
1. EU Approval of Itvisma for SMA
The European Commission approved Itvisma (onasemnogene abeparvovec) for treatment of children aged two years and older, teenagers and adults with 5q spinal muscular atrophy caused by bi-allelic SMN1 mutations. The one-time, fixed-dose intrathecal injection, supported by STEER, STRENGTH and STRONG trials, delivered a mean 2.39-point gain in the Hammersmith Functional Motor Scale at 52 weeks, making Itvisma the only gene replacement therapy approved for this broader patient population in the EU.
2. Dupilumab Posts Record Global Sales
Dupilumab reached $11.9 billion in global sales, with €10.7 billion in 2023 and $4.34 billion in Q2 2025. The drug’s expansion into COPD following FDA clearance in September 2024 and pediatric chronic spontaneous urticaria, coupled with clinical advantages over competitors, supports market projections through 2034 across multiple regions.
