Novartis' Itvisma® Offers Hope for Spinal Muscular Atrophy Patients

Digital DNA strands and molecular structures depict spinal muscular atrophy gene replacement therapy.

Novartis Breaks New Ground with Itvisma® Approval

On November 26, 2025, the U.S. Food and Drug Administration (FDA) granted approval for Novartis’ Itvisma® (onasemnogene abeparvovec-brve), the first gene replacement therapy specifically designed for Spinal Muscular Atrophy (SMA) in patients aged two years and older. This groundbreaking treatment targets the root genetic cause of SMA, which arises from mutations in the survival motor neuron 1 (SMN1) gene, leading to progressive muscle weakness and loss of motor function.

A Significant Step for Neuromuscular Disorders

Dr. John W. Day, a leading neurologist at Stanford University, described this FDA approval as a "game-changing advance" not just for SMA treatment but also for the future of neurological disorders and genetic medicine. Unlike previous therapies that required ongoing dosages, Itvisma® offers a one-time administration of gene replacement, drastically changing the therapeutic landscape for SMA patients.

The Importance of Addressing Older Patients

Historically, most treatments focused on infants and young children. However, as noted by Kenneth Hobby, president of Cure SMA, the approval now extends vital treatment options to older children, teens, and adults who have long faced the challenges of living with SMA. Approximately 9,000 people in the U.S. currently live with this rare neuromuscular disease, emphasizing the need for diverse therapeutic options.

Patient Support Services

With the introduction of Itvisma®, Novartis is also rolling out extensive patient support programs to ensure that individuals in Sussex County, NJ, and surrounding areas can access the therapy. Interested patients should reach out to Novartis Patient Support at 1-855-441-4363 for assistance with treatment initiation and potential financial aid. Access to this innovative treatment represents a significant milestone for those grappling with SMA and highlights the strides being made in rare disease treatments.

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Novartis' Itvisma® Offers Hope for Spinal Muscular Atrophy Patients

Novartis Breaks New Ground with Itvisma® Approval

A Significant Step for Neuromuscular Disorders

The Importance of Addressing Older Patients

Patient Support Services

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