BASEL (dpa-AFX) - Novartis AG (NVS) said that the U.S. Food and Drug Administration (FDA) has approved Itvisma for the treatment of individuals aged 2 years and older with spinal muscular atrophy (SMA) who have a confirmed mutation in the survival motor neuron 1 (SMN1) gene.
The company noted that Itvisma is the first and only gene-replacement therapy approved for this wide group of patients.
The approval is supported by results from the Phase III STEER trial and the Phase IIIb STRENGTH study. In the Phase III program, Itvisma demonstrated improved motor function and stabilization in patients regardless of prior SMA treatment history.
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