Novartis’s $2.59 Million Itvisma Gets FDA Nod—Can It Conquer the SMA Market?

The FDA’s recent green light for Novartis’s gene therapy Itvisma marks a major commercial and clinical milestone for the Swiss drugmaker. Itvisma is an updated version of Zolgensma, previously limited to infants under age 2 with spinal muscular atrophy (SMA), and will now treat older patients aged 2 and up. This approval significantly expands the addressable market for one of the rare commercial successes in the struggling gene therapy sector. With Zolgensma generating $1.2 billion in annual sales and analysts forecasting $510 million in revenue for Itvisma by 2027, Novartis is poised to strengthen its leadership in SMA therapeutics. The FDA’s decision was based on the STEER Phase 3 trial, which showed meaningful motor function improvement in older children. Pricing remains steep at $2.59 million, but Novartis argues this is 35–46% cheaper over ten years than chronic therapies.