By Stephen Nakrosis

Novartis secured approval for its drug to treat certain patients diagnosed with spinal muscular atrophy from the Food and Drug Administration.

Itvisma, or onasemnogene abeparvovec-brve, was approved for the treatment of patients two years of age and older living with spinal muscular atrophy with a confirmed mutation in the survival motor neuron 1 gene, the company said Monday A one-time dose of Itvisma replaces the SMN1 gene, potentially reducing the need for chronic treatment, Novartis said.

Spinal muscular atrophy is a rare, genetic neuromuscular disease caused by a mutated or missing SMN1 gene. The gene produces most of a protein needed by the body for muscle function, including breathing and basic movement, Novartis said.

The company added about 9,000 people in the U.S. live with spinal muscular atrophy.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

November 24, 2025 17:38 ET (22:38 GMT)

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