The U.S. Food and Drug Administration has approved a Novartis gene therapy for patients with a rare muscle disorder. The company announced the decision on Monday.

The therapy, sold as Itvisma, is cleared for people aged two years and older with a confirmed mutation in the survival motor neuron 1 gene. The condition, known as spinal muscular atrophy, limits production of a protein essential for muscle function.

Itvisma uses the same active ingredient found in Zolgensma, an older Novartis treatment already approved in the United States for patients under the age of two. The new option broadens access to gene replacement therapy across a wider age group.

Novartis said Itvisma is the first gene replacement therapy available for the full population affected by the disorder. A company executive said the approval increases treatment choices for patients.

The therapy has a wholesale acquisition cost of $2.59 million. Zolgensma carries a price of $2.1 million. Both products are designed as one-time treatments that replace the missing or mutated SMN1 gene.

In a late-stage study, Itvisma produced a statistically significant 2.39-point improvement on a scale measuring motor function and disease progression. The disease affects basic activities such as breathing, swallowing and movement.

Spinal muscular atrophy is the leading genetic cause of infant deaths. About 9,000 people in the United States live with the condition.

Itvisma differs from Zolgensma in how it is administered. Zolgensma is delivered intravenously based on patient weight. Itvisma is a concentrated formulation given directly into the central nervous system through the spinal cord. Novartis said the new therapy does not require weight-based adjustments.

Both treatments offer an alternative to chronic therapies used in this population. Novartis reported that Zolgensma generated $925 million in global sales during the first nine months of 2025.

The approval was announced after interviews with company executives and followed review by the U.S. regulator.