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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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.